Philips recalls HeartStart XL Defibrillators (Model M4735A) for potential incorrect shock delivery due to a faulty therapy switch. All units are affected and have been discontinued.
The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.
Philips is recalling its HeartStart XL Defibrillator/Monitor (Model M4735A) because a faulty rotary therapy switch could cause the device to malfunction, potentially delaying life-saving shocks. This device is intended for hospital use by trained medical personnel only.
The rotary therapy switch may fail, causing the device to not turn on, not perform selected functions, or deliver shocks at incorrect energy levels. This could delay critical therapy delivery during cardiac emergencies.
Healthcare professionals using the device in hospitals are affected. The risk is highest for medical staff who rely on the device for critical cardiac emergencies.
The device is labeled as the Philips HeartStart XL Defibrillator/Monitor with model number M4735A. It is intended for hospital use by qualified medical personnel only.
Identify the model number on the device label to confirm it is M4735A.
Reach out to Philips for guidance on next steps since all units have been discontinued.
The device has been discontinued and is not safe for use due to potential malfunction risks.
This device is intended for hospital use by qualified medical personnel trained in cardiac emergencies.
All units have been discontinued, so there are no replacements available.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2053-2020 — Philips Philips Hello, I own a Philips that is covered by recall Z-2053-2020 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.
