Physio-Control recalls LIFEPAK 15 defibrillators with specific model numbers due to an out of tolerance tool used during manufacturing, potentially causing system failure.
Due to an out of tolerance tool being used on monitor/defibrillator systems.
Physio-Control is recalling specific models of LIFEPAK 15 defibrillators because an out of tolerance tool was used during manufacturing. This could lead to system failure during use, which is serious for medical devices.
An out of tolerance tool was used during manufacturing, which could cause the defibrillator system to malfunction. This might lead to system failure during critical medical procedures, such as cardiac defibrillation.
Healthcare professionals using the LIFEPAK 15 defibrillators with the listed model numbers are most at risk. Patients receiving defibrillation care using these devices could be affected if the system fails.
Check the model numbers listed in the recall notice (e.g., 97577-000101, 99577-000046) or the serial numbers provided. The device is intended for use as a monitor/defibrillator in medical settings.
Verify the model number on your LIFEPAK 15 device against the list of recalled numbers provided in the recall notice.
Reach out to Physio-Control directly for further assistance or to confirm if your device is affected.
Physio-Control recalls specific LIFEPAK 15 models due to an out of tolerance tool used during manufacturing, which could cause system failure during use.
Check the model numbers listed in the recall notice (e.g., 97577-000101, 99577-000046) or the serial numbers provided. The device is intended for use as a monitor/defibrillator in medical settings.
Contact Physio-Control directly to confirm if your device is affected and for further instructions.
We’ve drafted a message you can send Physio-Control to request your refund or repair — edit it as you like.
Subject: Recall Z-0230-2025 — Physio-Control Physio-Control Hello, I own a Physio-Control that is covered by recall Z-0230-2025 from Physio-Control. 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.