Philips heartstart pads recall

Author: lkpb

August undefined, 2024

WebbThe HS1 AED provides practically real-time guidance through step-by-step voice commands from pad placement to performing CPR. When every minute counts, Philips HeartStart HS1 AED is the partner by your side. Side by side. Step by step. Contact us Features Documentation Specifications Related products AED consumables and supplies 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.

Premarket Approval (PMA) - Food and Drug Administration

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 … WebbPhilips 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 … can being dirty make you sick

Medical Device Recall on 2024-03-02 for Philips M5071A

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, 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. 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. WebbAny 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 fishing dora creek

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

HeartStart AEDs Philips

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 … 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, … can being depressed make you coughWebbCall 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 … can being drunk cause a heart attack

"Webb4 feb. 2024 · Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS: Code Information: ALL LOTS : Recalling Firm/ … " - Philips heartstart pads recall

Philips heartstart pads recall

AED Pads Medical Device Correction Notice Philips

WebbTo replace your HeartStart pads, locate the latch at the top edge of the AED and slide it to the side to release the pads cartridge. Lift out the used cartridge. Remove a new SMART … Webb9 feb. 2024 · Class 2 Device Recall Philips, HeartStart FR2 Defibrillator. Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514. Customers were not notified of previous recalls associated with various defibrillator models. On February 11, 2024, Philips issued a …

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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. 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;

Webb28 juli 2024 · A problem has been identified in certain philips m5072a heartstart infant/child smart pads cartridges (lot y111220-01) which are used with the philips … 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, 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.

Webb14 mars 2024 · Recalling Firm/ Manufacturer: Philips Electronics North America Corp. 22100 Bothell Everett Hwy Bothell WA 98021-8431: For Additional Information Contact: … WebbThe 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 …

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 …

Webb16 juli 2024 · Recall Number: Z-2427-2024: Recall Event ID: 88361: PMA Number: P160029 : Product Classification: Pads for Automated external defibrillators (non-wearable) - … can being depressed make you nauseousWebbPhilips 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 … fishing dosewallips riverWebbPhilips 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 ... fishing doorWebbPhilips issued an Emergency Medical Device Correction 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 … fishing doradoWebbPhilips Healthcare Heartstart FRx AED with 2X Battery, 2X Pads, Infant Key, Case can being distracted help with depressionWebbField 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 ... fishing door countyWebbRecall 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 … fishing dories