Physio-Control Recalls LIFEPAK 20e Defibrillators Due to Power Failures
Physio-Control is recalling 3,831 LIFEPAK 20e defibrillators because power-related failures could prevent the device from delivering therapy, potentially causing serious injury or death.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect has the potential to result in 'serious injury or death,' which aligns with the rubric criteria for a Severe (4) rating involving significant injury reports or potential for serious harm.
Plain-English summary
Physio-Control, Inc. is recalling 3,831 units of the LIFEPAK 20e Defibrillator/Monitor (Catalog Number 3201273). The devices were distributed worldwide and are intended for use in hospitals, physician offices, and clinics by authorized medical personnel.
The recall is due to power-related failures that may occur during initial deployment or within the first year of use. Symptoms of these failures include unexpected power on/off, device lock-up, or failure to power on/off. These issues have the potential to result in a failure to deliver therapy to the patient, which could lead to serious injury or death.
Physio-Control has not reported any illnesses or injuries associated with this defect. Healthcare facilities should check their inventory for the affected serial numbers listed in the recall notice and contact Physio-Control for instructions on how to proceed.
The recalled product
- Product
- LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 3,831
Distribution
Distribution scope not specified by the agency.
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