LIFEPAK 1000 defibrillators recalled for missed required post-service inspections
Physio-Control is recalling three LIFEPAK 1000 defibrillators due to required inspections not being performed after servicing. The affected units were distributed in Colorado and Montana.
What this means for you
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: FDA Class II medical device recall with no reported illnesses or injuries. The hazard is non-compliance with required post-service inspections, representing a risk-of-harm scenario for a critical medical device where actual harm has not been reported. This meets the criteria for High severity.
Plain-English summary
Physio-Control, Inc. is recalling three LIFEPAK 1000 defibrillators (models 320371500023, 320371500229, and 331706400001). The LIFEPAK 1000 is an automated external defibrillator (AED) for use in patients experiencing cardiac arrest.
The recall was initiated because required inspections were not performed on these units after they underwent servicing. Post-service inspections are mandatory to verify device operation and safety. The three affected units were distributed in Colorado and Montana.
The recalled product
- Product
- LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardio
- Manufacturer
- Physio-Control, Inc.
- Hazard
- missed-inspections
- malfunction-risk
Distribution
Distributed nationwide across the United States.
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