If a device is covered by this notification and is still under warranty, you may optionally receive a refurbished exchange unit at no cost. Q: Are the AEDs under this recall safe to use? WebDearCustomer, AproblemhasbeenidentifiedinthePhilipsM5071A(adult)andM5072A(infant/child)AEDpadsthatcouldpose ariskforpatientsorusers.ThisURGENTCorrectionisintendedtoinformyouabout: 1.Whattheproblemisandunderwhatcircumstancesitcanoccur To request a warranty exchange unit or a trade-in rebate, or to obtain additional information, contact your local Philips representative. 3. Please respond, even if you no longer own the AED. If a device is no longer under warranty or if you wish to purchase a newer model replacement for their present AED, as an owner of a Philips HeartStart FRx, HS1 OnSite, or HS1 Home AED affected by this action, you may be eligible for a trade-in rebate. WebPhilips is offering trade-in rebates depending on the age and model of the affected AED. Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. Recall Philips, HeartStart HS1 OnSite Defibrillator Philips AED Recall Due to customer feedback, we have decided to notify customers who received an HSI/OnSite/Home AED more than 10 years ago. All you need to do is open the AED and follow the clear, calm voice instructions. Q: Are the affected AEDs being removed from service? 4. WebDearCustomer, AproblemhasbeenidentifiedinthePhilipsM5071A(adult)andM5072A(infant/child)AEDpadsthatcouldpose ariskforpatientsorusers.ThisURGENTCorrectionisintendedtoinformyouabout: 1.Whattheproblemisandunderwhatcircumstancesitcanoccur By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. WebPhilips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart OnSite). Health product recall HEARTSTART DEFIBRILLATION PADS (2021-07-28) Starting date: July 28, 2021 Posting date: August 10, 2021 Type of communication: Medical Device Recall Subcategory: Medical Device Hazard classification: Type II Source of recall: Health Canada Issue: Medical Devices Audience: General Public, Healthcare AED recall Visit www.philips.com/aedaudiblechirps to hear an example. Customers were not notified of previous recalls associated with various defibrillator models. If your device is no longer under warranty, or if you desire to purchase a newer model replacement for your present AED, you may be eligible for a trade-in rebate. AED Pads Recall Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge and the Infant/Child SMART Pads Cartridge for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite). Order replacement batteries and pads for your Philips HeartStart AED. HeartStart OnSite AED News. WebIf an AED has ever emitted or begins to emit a pattern of triple chirps, call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. URGENT - Medical Device Recall on Philips OnSite AED SMART pads cartridges. If an AED has ever emitted or begins to emit a pattern of triple chirps, please call Philips customer service. AED A: No, it is not required to replace affected AEDs because when used in accordance with Instructions for Use and other labeling, including this recall/notification, the HS1/OnSite/Home and FRx devices are effective and safe to use. Youll be told how put the pads on the victim In the United States, contact Philips directly at 1-800-263-3342. Trusted On December 14, 2022, Philips issued an Urgent Medical Device Correction - Expansion notification, dated November 15, 2022. WebThe Philips AED will analyze the heart rhythm and tell you to deliver a shock, if and only if the victim needs it. WebPhilips issued an Emergency Medical Device Notice regarding a potential gel peeling issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite) Koninklijke Philips N.V., 2004 - 2023. URGENT - Medical Device Recall on Philips OnSite AED SMART pads cartridges. AEDs WebThe OnSite automated external defibrillator provides practically real-time guidance through step-by-step voice commands from pad placement to performing CPR. You can learn more on Philips website. Philips If you need any further information or support concerning this issue, please contact Philips at 1 (800) 263-3342. A: Yes. Recall Philips, HeartStart HS1 Home Defibrillator Please respond, even if you no longer own the AED. Affected AEDs are not recommended to be removed from service. WebPhilips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart OnSite). AED recall A: No. Philips Philips HeartStart OnSite AED Class 2 Device Recall Philips, HeartStart HS1 Home Defibrillator. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland. WebIf an AED has ever emitted or begins to emit a pattern of triple chirps, call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. If a device is no longer under warranty or if you wish to purchase a newer model replacement for their present AED, as an owner of a Philips HeartStart FRx, HS1 OnSite, or HS1 Home AED affected by this action, you may be eligible for a trade-in rebate. 1. On February 11, 2021, Philips issued a "Urgent - Safety Notification" to affected consignees via certified Mail. To request a warranty exchange unit or a trade-in rebate, or to obtain additional information, contact your local Philips representative. If an AED has ever emitted or begins to emit a pattern of triple chirps, call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. WebThe OnSite automated external defibrillator provides practically real-time guidance through step-by-step voice commands from pad placement to performing CPR. Q: Are the affected AEDs being removed from service? HEARTSTART DEFIBRILLATION PADS (2021-07 This page provides additional information regarding the February 2018 notification/recall of HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs (Philips FSN86100186). Class 2 Device Recall Philips, HeartStart HS1 Home Defibrillator. WebThe Philips AED will analyze the heart rhythm and tell you to deliver a shock, if and only if the victim needs it. You can learn more on Philips website. 7. If your device is no longer under warranty, or if you desire to purchase a newer model replacement for your present AED, you may be eligible for a trade-in rebate. Recall Status 1: Open 3, Classified: Recall Number: Z-0081-2022: Recall Event ID: 88637: PMA Number: P160029 : Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Product: Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A: Code Information If you wish to confirm whether your device is affected and therefore potentially eligible for one of the warranty replacement or trade-in programs, please call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. A Philips representative will reach out to you to help you identify any affected AED. Recall Status 1: Open 3, Classified: Recall Number: Z-0081-2022: Recall Event ID: 88637: PMA Number: P160029 : Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Product: Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A: Code Information Affected AEDs are not recommended to be removed from service. Philips URGENT - Medical Device Recall on Philips OnSite AED SMART pads cartridges. U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. WebDearCustomer, AproblemhasbeenidentifiedinthePhilipsM5071A(adult)andM5072A(infant/child)AEDpadsthatcouldpose ariskforpatientsorusers.ThisURGENTFieldSafetyNoticeisintendedtoinformyouabout: 1.Whattheproblemisandunderwhatcircumstancesitcanoccur AEDs Affected serial numbers for Model # 5068A: A10A-01936, A09J-02570, A04L-01521, A10H-04433, A09J-01944, A07H-03121, A08A-03450, A08A-05842, 1007257517. Youll be told how put the pads on the victim Philips AED Recall It will be formatted like this: A0XX-XXXXX. Philips AED recall | Philips WebDearCustomer, AproblemhasbeenidentifiedinthePhilipsM5071A(adult)andM5072A(infant/child)AEDpadsthatcouldpose ariskforpatientsorusers.ThisURGENTFieldSafetyNoticeisintendedtoinformyouabout: 1.Whattheproblemisandunderwhatcircumstancesitcanoccur Email to: ECR.Recall.Response@Philips.com WebPhilips issued an Emergency Medical Device Notice regarding a potential gel peeling issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite) Order replacement batteries and pads for your Philips HeartStart AED. Philips is offering trade-in rebates depending on the age and model of the affected AED. WebFebruary 2022. If a device is covered by this notification and is still under warranty, you may optionally receive a refurbished exchange unit at no cost. may be reported to the FDA s Med Watch Adverse Event Reporting program Class 2 Device Recall Philips, HeartStart HS1 Home Defibrillator. AED Pads WebPhilips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart OnSite). Click here for an important announcement on Philips Sleep and Respiratory Care devices . Affected AEDs are not recommended to be removed from service. Recall Philips, HeartStart HS1 OnSite Defibrillator WebIf an AED has ever emitted or begins to emit a pattern of triple chirps, call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. The recall was issued due to the potential for the AED pad gel to separate from the foam/tin backing when peeled from the plastic liner. AED recall The information is directed exclusively to health professionals, health practitioners, persons who are purchasing officers in hospitals, and persons who are engaged in the business of wholesaling therapeutic goods (as per s42AA of the Therapeutic Goods Act 1989 (Cth), and s6 of the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021). 5. Due to customer feedback, we have decided to notify customers who received an HSI/OnSite/Home AED more than 10 years ago. Recall PHILIPS Replacement options are being offered as a courtesy. Adverse reactions or quality problems experienced with the use of this product Recall PHILIPS You are entering a Philips Healthcare Australia website, Radiography | X-ray & Fluoroscopy Solutions, A: Yes. Recall PHILIPS In the United States, contact Philips directly at 1-800-263-3342. The serial number for the HeartStart FRx starts with the letter B, followed by 8 numbers and letters. Visit www.philips.com/aedaudiblechirps to hear an example. Recall Q: Are the affected AEDs being removed from service? Visit www.philips.com/aedaudiblechirps to hear an example. When every minute counts, Philips HeartStart OnSite defibrillator is Visit www.philips.com/aedaudiblechirps to hear an example. Customers were not notified of previous recalls associated with various defibrillator models. The information on this site is not intended for consumers. WebDearCustomer, AproblemhasbeenidentifiedinthePhilipsM5071A(adult)andM5072A(infant/child)AEDpadsthatcouldpose ariskforpatientsorusers.ThisURGENTFieldSafetyNoticeisintendedtoinformyouabout: 1.Whattheproblemisandunderwhatcircumstancesitcanoccur A: No. WebIn April 2022, Philips initiated Recall for Product Correction for the M5071A Adult and M5072A Infant/child pads cartridges for use with HSI/OnSite/Home AEDs. By clicking Continue you are indicating that you are one of the intended audiences. Philips will exchange affected devices with a replacement Philips AED free of charge. To request a warranty exchange unit or a trade-in rebate, or to obtain additional information, contact your local Philips representative. Recall Philips, HeartStart FR2 Defibrillator In addition to notifying consignees that may have been omitted from notification of one or more recalls, Philips asked affected consignees to take If an AED has ever emitted or begins to emit a pattern of triple chirps, call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. Philips A: Yes. Recall Philips, HeartStart FR2 Defibrillator Note: If you need help accessing information in different file formats, see To request a warranty exchange unit or a trade-in rebate, or to obtain additional information, contact your local Philips representative. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. If you received a recall/notification letter from Philips, our records indicate you possess an affected device. If your device is still under warranty, you are entitled to receive a refurbished exchange unit at no cost, in accordance with our standard warranty terms. Visit. Recall Status 1: Open 3, Classified: Recall Number: Z-0078-2022: Recall Event ID: 88637: 510(K)Number: K051632 Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Product: Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A: Code Information AED Recall Philips is offering trade-in rebates depending on the age and model of the affected AED. either online, by regular mail or by fax. The affected AED may remain in service until you receive a replacement Philips AED. AED recall WebThe Philips AED will analyze the heart rhythm and tell you to deliver a shock, if and only if the victim needs it. WebDearCustomer, AproblemhasbeenidentifiedinthePhilipsM5071A(adult)andM5072A(infant/child)AEDpadsthatcouldpose ariskforpatientsorusers.ThisURGENTCorrectionisintendedtoinformyouabout: 1.Whattheproblemisandunderwhatcircumstancesitcanoccur HeartStart OnSite AED Recall Philips, HeartStart HS1 Home Defibrillator Q: Are the AEDs under this recall safe to use? This page provides additional information regarding the February 2018 notification/recall of HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs (Philips FSN86100186). Visit www.philips.com/aedaudiblechirps to hear an example. In the United States, contact Philips directly at 1-800-263-3342. On April 6, 2022 the FDA in conjunction with Phillips issued a Class 2 Device Recall for the PHILIPS ADULT SMART PADS CARTRIDGE. If an AED has ever emitted or begins to emit a pattern of triple chirps, call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. WebFebruary 2022. Affected serial numbers for Model # 5068A: A10A-01936, A09J-02570, A04L-01521, A10H-04433, A09J-01944, A07H-03121, A08A-03450, A08A-05842, 1007257517. You are about to visit a Philips global content page. Visit www.philips.com/aedaudiblechirps to hear an example. After it has been confirmed that you have an affected AED and a replacement Philips AED has been sent to you, please return the affected AED to Philips using the shipping label to be provided. AED recall The devices may continue to be used. All you need to do is open the AED and follow the clear, calm voice instructions. Recall Status 1: Open 3, Classified: Recall Number: Z-0081-2022: Recall Event ID: 88637: PMA Number: P160029 : Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Product: Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A: Code Information Recall Philips, HeartStart FR2 Defibrillator A: No, it is not required to replace affected AEDs because when used in accordance with Instructions for Use and other labeling, including this recall/notification, the HS1/OnSite/Home and FRx devices are effective and safe to use. AED Pads Due to this situation, Onsite AEDs are not available. When every minute counts, Philips HeartStart OnSite defibrillator is On December 14, 2022, Philips issued an Urgent Medical Device Correction - Expansion notification, dated November 15, 2022. Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge and the Infant/Child SMART Pads Cartridge for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite). Customers were not notified of previous recalls associated with various defibrillator models. Philips AED AED Recall It will be formatted like this: B0XX-XXXXX. Model M3861A affected serial numbers: A09H-00436 and A07J-03514. The devices may continue to be used. WebIf an AED has ever emitted or begins to emit a pattern of triple chirps, call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. AED recall Philips Customers were not notified of previous recalls associated with various defibrillator models. WebIn April 2022, Philips initiated Recall for Product Correction for the M5071A Adult and M5072A Infant/child pads cartridges for use with HSI/OnSite/Home AEDs. AEDs Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Automated external defibrillators (non-wearable), 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS, Instructions for Downloading Viewers and Players, Class 2 Device Recall Philips, HeartStart FR2 Defibrillator, Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A, Model M3860A affected serial numbers: A09G-04198 and 510800626 AED Pads HEARTSTART DEFIBRILLATION PADS (2021-07 Q: Are the affected AEDs being removed from service? All rights reserved. On April 6, 2022 the FDA in conjunction with Phillips issued a Class 2 Device Recall for the PHILIPS ADULT SMART PADS CARTRIDGE. The serial number for HeartStart HS1, HeartStart Onsite and HeartStart Home starts with the letter A, followed by 8 numbers and letters. In the United States, contact Philips directly at 1-800-263-3342. Recall Status 1: Open 3, Classified: Recall Number: Z-0078-2022: Recall Event ID: 88637: 510(K)Number: K051632 Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Product: Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A: Code Information WebIf an AED has ever emitted or begins to emit a pattern of triple chirps, call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. Health product recall HEARTSTART DEFIBRILLATION PADS (2021-07-28) Starting date: July 28, 2021 Posting date: August 10, 2021 Type of communication: Medical Device Recall Subcategory: Medical Device Hazard classification: Type II Source of recall: Health Canada Issue: Medical Devices Audience: General Public, Healthcare WebPhilips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite). In the United States, contact Philips directly at 1-800-263-3342. Recall Status 1: Open 3, Classified: Recall Number: Z-0078-2022: Recall Event ID: 88637: 510(K)Number: K051632 Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Product: Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A: Code Information The devices may continue to be used. Q: Are the AEDs under this recall safe to use? AED recall | Philips WebFebruary 2022. A: Yes. Recall Philips, HeartStart HS1 Home Defibrillator On April 6, 2022 the FDA in conjunction with Phillips issued a Class 2 Device Recall for the PHILIPS ADULT SMART PADS CARTRIDGE. AED Recall Trusted Due to this situation, Onsite AEDs are not available. 2. Affected AEDs are not recommended to be removed from service. If your device is still under warranty, you are entitled to receive a refurbished exchange unit at no cost, in accordance with our standard warranty terms. Philips The devices may continue to be used. WebPhilips is offering trade-in rebates depending on the age and model of the affected AED. The devices may continue to be used. Q: Are the affected AEDs being removed from service? Please respond, even if you no longer own the AED. The devices may continue to be used. News. Order replacement batteries and pads for your Philips HeartStart AED. Your serial number can be found on the back of your device next to the battery well. Instructions for Downloading Viewers and Players. Recall Philips, HeartStart HS1 OnSite Defibrillator AED Pads You can learn more on Philips website. All you need to do is open the AED and follow the clear, calm voice instructions. Recall Visit www.philips.com/aedaudiblechirps to hear an example. Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge and the Infant/Child SMART Pads Cartridge for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite). Medical Device Recall on 2022-03-02 for Philips M5071A (adult) and M5072A (infant/child) AED pads - AED4Life. The devices may continue to be used. WebPhilips issued an Emergency Medical Device Notice regarding a potential gel peeling issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite) 6. AED recall | Philips Or, Fax: 1 (833) 371-1011 The recall was issued due to the potential for the AED pad gel to separate from the foam/tin backing when peeled from the plastic liner. WebPhilips is offering trade-in rebates depending on the age and model of the affected AED.
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