Philips recalls HeartStart FRx AED model 861304 with FRx codeRev E.02.017 due to potential quality issues in the Printed Circuit Assembly. Affected units may not function properly.
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
Philips is recalling its HeartStart FRx AED devices with specific model and software versions because the internal Printed Circuit Assembly (PCA) was not made or repaired to quality standards. This could lead to the device not working correctly, which is important for users who rely on the device for emergencies.
The recalled devices contain a Printed Circuit Assembly that was not manufactured or repaired according to quality standards. This could cause the device to malfunction, potentially failing to deliver life-saving shocks during a cardiac emergency.
Owners of Philips HeartStart FRx AED devices with model 861304 and software version FRx codeRev E.02.017 are affected. People who use these devices for medical emergencies are most at risk if the device fails to function properly.
Check for the model number 861304 and software version FRx codeRev E.02.017 on the device. The system serial numbers listed in the recall notice are also unique identifiers for affected units.
Review the model number and software version on your Philips HeartStart FRx AED to see if it matches the recalled specifications.
The recall is due to the Printed Circuit Assembly not being manufactured or repaired to quality standards, which could cause the device to malfunction.
Check for the model number 861304 and software version FRx codeRev E.02.017 on your device. The system serial numbers listed in the recall notice are also unique identifiers for affected units.
The recall does not specify a remedy, so you should check with Philips directly for further instructions.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1271-2020 — Philips Philips Hello, I own a Philips that is covered by recall Z-1271-2020 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.
