LIFEPAK 15 defibrillators recalled for missing post-service quality inspections
Physio-Control is recalling LIFEPAK 15 defibrillators because required inspections were not performed after servicing. Four units distributed in Colorado and Montana are affected.
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: This is a risk-of-harm medical device recall where required quality inspections were not performed after servicing, but no injuries or illnesses have been reported. The missing inspections on a critical life-saving defibrillator create potential for device malfunction during emergency use.
Plain-English summary
Physio-Control, Inc. is recalling LIFEPAK 15 defibrillators used in emergency medical settings. The LIFEPAK 15 (LP15) is designed for use by trained medical personnel in out-of-doors and indoor emergency care settings for both adult and pediatric patients, with automated external defibrillation available for patients eight years of age and older.
The recall was initiated because required inspections were not performed on four units that underwent servicing. These inspections are critical to verify device functionality and safety after maintenance work.
Four affected units have been distributed in Colorado and Montana. Affected units can be identified by their catalog and serial numbers: V15-7-000022 (SN 49085553), V15-2-000051 (SN 38154524), V15-2-000099 (SN 39059475), and V15-2-001603 (SN 40973093).
Healthcare facilities and medical personnel in possession of these units should contact Physio-Control, Inc. immediately to verify the status of their devices and arrange for proper inspection.
The recalled product
- Product
- LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained
- Manufacturer
- Physio-Control, Inc.
- Hazard
- inspection-failure
- malfunction-risk
Distribution
Distributed nationwide across the United States.
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