Philips recalls HeartStart MRx Monitor/Defibrillator Model M3535A due to potential non-conforming devices that may not have been corrected in prior actions. Affected units include specific lot numbers.
Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.
Philips is recalling HeartStart MRx Monitor/Defibrillator Model M3535A because some units may not have been corrected in previous actions. This could mean the devices might not function properly, but the recall does not specify a risk of injury or harm.
The recall states that non-conforming devices may not have been included in prior field actions and may not have had necessary corrections. This means some units could be defective but the record does not specify how the defect causes harm or injury.
Healthcare professionals and others who use the HeartStart MRx defibrillator for medical emergencies may be affected. The most at-risk users are those who rely on the device for defibrillation therapy.
Check for the model number M3535A on the device. Affected units have lot numbers US00539461 or US00539462.
Look for the model number M3535A on the HeartStart MRx defibrillator.
The recall states that non-conforming devices may not have been included in prior field actions and may not have had necessary corrections. The record does not specify a risk of injury or harm.
The recall does not provide specific action steps beyond checking the model number and lot numbers. Affected units include specific lot numbers US00539461 and US00539462.
The recall does not mention any risk of injury or harm. The hazard description focuses on non-conforming devices that may not have been corrected.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2488-2019 — Philips Philips Hello, I own a Philips that is covered by recall Z-2488-2019 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
