Physio-Control Recalls LIFEPAK 1000 Defibrillators Due to Unexpected Shutdowns
Physio-Control is recalling 96,611 LIFEPAK 1000 defibrillators because a software malfunction can cause the device to shut down unexpectedly, potentially failing to deliver a life-saving shock.
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 is classified as FDA Class II. The hazard involves a life-saving device failing to deliver therapy during cardiac arrest, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Physio-Control, Inc. is recalling 96,611 units of the LIFEPAK 1000 defibrillator (affected part numbers 320371500XXX). The recall affects devices distributed worldwide, including 40,974 units in the United States and 55,637 units in other countries. The device is indicated for use on patients in cardiac arrest when in AED mode.
The recall was initiated after Physio-Control became aware of incidents where customers attempted to use the defibrillator and the device shut down unexpectedly due to a very low battery. This shutdown is attributed to a software malfunction. In this scenario, the defibrillator has the potential to fail to deliver a shock, which could result in therapy not being delivered and a patient not being resuscitated.
The source text does not report any specific injuries, illnesses, or fatalities associated with these incidents. Affected units are identified by specific serial numbers listed for the US Department of Defense, Veterans Hospitals, and US Consignees. Users should check their device serial numbers against the recall list and follow instructions from Physio-Control or the FDA regarding the recall.
The recalled product
- Product
- LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
Distribution
Distributed nationwide across the United States.
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