Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators for Unexpected Power Loss
Physio-Control is recalling 1,399 LIFEPAK 15 monitor/defibrillators because they may power down unexpectedly during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (defibrillator) with a functional defect (unexpected power loss) that could impact emergency care, but no injuries or illnesses have been reported.
Plain-English summary
Physio-Control, Inc. is recalling 1,399 units of the LIFEPAK 15 monitor/defibrillator. The recall involves 866 units in the United States and 533 units outside the United States. The devices are intended for use by trained medical personnel in emergency care settings.
The recall was initiated due to a customer complaint regarding a device that powered on and then powered down unexpectedly after a short period of use. The issue occurred when the device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. Power could be immediately restored by activating the power button after the device powered down.
The corrective action for this issue was completed by Velocitor Solutions in December 2010. Velocitor Solutions notified their customers of this action in 2010. The consignee list was not provided to Physio-Control.
The recalled product
- Product
- The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX
- Manufacturer
- Physio-Control, Inc.
- Hazard
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
- ModerateDefibrillator recalled because required post-service inspections were not performed
FDA (Devices) · 2025-09-10
- ModerateLIFEPAK 15 defibrillators recalled because post-service inspections were not performed
FDA (Devices) · 2025-09-10
- ModerateLIFEPAK 1000 defibrillators recalled over inspections missed after unit servicing
FDA (Devices) · 2025-09-10
Same hazard · power loss
See all →- HighHumidifier devices recalled because power loss alert sounds under two minutes
FDA (Devices) · 2025-10-22
- HighBD Pyxis Medication Dispensing Devices Labeling Update Addresses Manual Access Risk
FDA (Devices) · 2025-03-05
- HighBronchoscopic system may lose power due to defective component
FDA (Devices) · 2024-12-25
- High2025 Polestar 3 Vehicles High to Low Voltage Converter Damage Recall
NHTSA · 2024-12-18
- HighZ-800 Infusion System Recalled for Battery Depletion Risk
FDA (Devices) · 2024-11-27
Similar recalls
- SeverePhysio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Lockup Condition
FDA (Devices) · 2019-03-06
- CriticalPhysio-Control Recalls LIFEPAK 1000 Defibrillators for Unexpected Power-Offs
FDA (Devices) · 2017-03-15
- SeverePhysio-Control Recalls LIFEPAK 20e Defibrillators Due to Power Failures
FDA (Devices) · 2018-01-17
- SeverePhysio-Control Recalls LIFEPAK 15 Monitor/Defibrillator Service Kits
FDA (Devices) · 2019-03-06
- 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