Philips heartstart pads recall

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August undefined, 2024

WebbPAD 450P AED. Learn More. Defibtech. LifeLine View. Learn More. ZOLL Plus AED Machine. Learn More. Philips Heartstart FRX AED. Learn More. Need Help Finding Your AED? Call an FC Safety AED Expert Today at (877) 665-7233. ... Actively Monitoring all of your AED’s to let you know of any manufacturer or FDA related recalls; WebbPhilips HeartStart OnSite Adult Smart Pads have specific weight and age guidelines: OnSite Adult SMART Pads can be used for adults and children who are 8 years old and older, and/or 55 pounds and over. There is a 2 …

Class 2 Device Recall Philips HeartStart Infant/Child SMART Pads …

WebbRecall Status 1: Terminated 3 on April 29, 2024: Recall Number: Z-2549-2024: Recall Event ID: 83681: 510(K)Number: K020715 Product Classification: Automated external … Webb4 feb. 2024 · Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS: Code Information: ALL LOTS : Recalling Firm/ … tslprb height

Philips Pad Recall - Action First Aid

Webb9 feb. 2024 · Email to: [email protected] Or, Fax: 1 (833) 371-1011 2. A Philips representative will reach out to you to help you identify any affected AED. 3. After … Webb3 mars 2014 · If you are affected contact Philips immediately for a replacement device at 1-800-263-3342 and select OPTION 5. Live technical support is available Monday through Friday, 7:00AM to 5:00PM PST. You can also leave a message 24 hours a day, seven days a week and a customer support representative will return your call promptly on the next … WebbThe recall affects only the Philips HeartStart OnSite, HS1, FRx and Home Defibrillator AEDs; The Philips HeartStart FR, Forerunner, FR2 and FR2+ AEDs are not affected, but these devices are old and should be replaced with newer life-saving devices like the OnSite model; Only AEDs manufactured from 2002 to early 2013 are affected by the ... tslprb office

Class 2 Device Recall PHILIPS ADULT SMART PADS CARTRIDGE

WebbThe AED is both defective and a risk to health. Depending on what action must take place, a recall will be either a correction or a removal. A correction, or corrective action, is a recall that addresses the problem with the AED by correcting the issue in the place where the device is used or sold. Webb9 feb. 2024 · Class 2 Device Recall Philips, HeartStart FR2 Defibrillator. Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial … tslprb releases allWebbThe recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefore … tslprb online apply

"WebbField Safety Notice (579.0KB) Philips 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. Philips has identified that for affected pads, some gel may fold onto itself, resulting in reduced surface area of ... " - Philips heartstart pads recall

Philips heartstart pads recall

WebbPhilips 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 … WebbPhilips is offering trade-in rebates depending on the age and model of the affected AED. To request a warranty exchange unit or a trade-in rebate, or to obtain additional information, …

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Webb14 mars 2024 · Recalling Firm/ Manufacturer: Philips Electronics North America Corp. 22100 Bothell Everett Hwy Bothell WA 98021-8431: For Additional Information Contact: … Webb5 feb. 2024 · Philips Pad Recall Philips M5071A (adult) and M5072A (infant/child) AED Pads A problem has been identified that could pose a risk for patients or users. HS1/OnSite/Home AED pads (PN: M5071A, M5072A) have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner.

WebbPhilips projects to release an update regarding pads later in 2024, dependent upon design activities, subcomponent availability, and regulatory approvals. Philips plans to notify eligible customers and supply updated pads. Are there substitute pads or other brands that can be used with the device? No. Only Philips HeartStart II pads are ... Webb10 apr. 2024 · The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at...

WebbPads Recall - Landing Page Form URGENT MEDICAL DEVICE RESPONSE FORM PHILIPS HEALTHCARE This form consists of 4 pages. Please make sure to SUBMIT SURVEY on page 4. Reference: M5071A and M5072A Instructions: Please complete no later than 30 days from receipt. Webb25 jan. 2024 · This Philips Respironics December 2024 update is intended to provide healthcare providers, patients, and other stakeholders with updated information on the …

WebbThe Philips HeartStart FRx defibrillator features intuitive, step-by-step voice instructions, including CPR guidance, and an audible metronome to help guide basic life support …

WebbCall 800-263-3342 Maintaining the HeartStart HS1/OnSite/Home Pads and Battery Maintaining the HeartStart FRx Pads and Battery Have the reliability you need – on hand … tslprb last date to apply 2022WebbPhilips 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 … tslprb registration tslprb latest newsWebbPhilips will provide redesigned replacement SMART Pads to all end users when these are available. Philips has received 115 complaints since 2010 (of which 84 complaints were … tslprb pc results nflWebbAny pad currently installed in or stored with an HS1/onsite/home aed could experience this problem, and it is not possible to know prior to patient use if your pad is affected because the pads are protected by a foil seal. Recall start date: Mar 2, 2024 Additional information Details Report a health or safety concern tslprb previous papersWebbPhilips is offering trade-in rebates depending on the age and model of the affected AED. To request a warranty exchange unit or a trade-in rebate, or to obtain additional information, contact your local Philips representative. In the United States, contact Philips directly at 1-800-263-3342. Q: Are the AEDs under this recall safe to use? A: Yes. tsl profileWebb3 mars 2024 · Reason. Philips has become aware that a HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED in customer's possession may have been omitted from one or more previous recalls or customer information notifications. Their records indicate that a potentially affected AED was shipped to a customer and the quantity affected, but the … tslprb pc mains syllabus