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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 3,831
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Physio-Control, Inc.
See all →- HighPhysio-Control Defibrillators May Lack Required Performance Inspection
FDA (Devices) · 2026-05-13
- HighInfant and child defibrillator electrodes recalled over pediatric electrode delamination
FDA (Devices) · 2026-03-18
- ModerateLIFEPAK 1000 defibrillators recalled over inspections missed after unit servicing
FDA (Devices) · 2025-09-10
- ModerateLIFEPAK 15 defibrillators recalled because post-service inspections were not performed
FDA (Devices) · 2025-09-10
- ModerateDefibrillator recalled because required post-service inspections were not performed
FDA (Devices) · 2025-09-10
Same hazard · power failure
See all →- CriticalCarestation 750 anesthesia systems recalled over potential unexpected shutdown
FDA (Devices) · 2025-12-24
- CriticalAnesthesia power management boards recalled over potential unexpected system shutdown
FDA (Devices) · 2025-12-24
- CriticalAnesthesia systems recalled over potential unexpected shutdown on mains power loss
FDA (Devices) · 2025-12-24
- HighBD FACSLyric 2L4C Flow Cytometer Power Supply Failure Recall
FDA (Devices) · 2025-01-01
- HighBD FACSLyric Flow Cytometer Power Supply Module Failure Risk
FDA (Devices) · 2025-01-01
Similar recalls
- HighPhysio-Control Recalls LIFEPAK 15 Monitor/Defibrillators for Unexpected Power Loss
FDA (Devices) · 2016-12-21
- CriticalPhysio-Control Recalls LIFEPAK 1000 Defibrillators for Unexpected Power-Offs
FDA (Devices) · 2017-03-15
- HighPhysio-Control Recalls LIFEPAK 1000 Defibrillators Due to Unexpected Shutdowns
FDA (Devices) · 2014-06-04
- SeverePhysio-Control Recalls LIFEPAK 15 Defibrillators Due to Relay Failure
FDA (Devices) · 2017-02-22
- HighLIFEPAK 15 defibrillator recalled for potential battery power loss
FDA (Devices) · 2023-11-22
- HighLIFEPAK 15 Monitor/Defibrillator Recalled Due to Manufacturing Tool Defect
FDA (Devices) · 2024-11-06