LIFEPAK 15 defibrillators recalled because post-service inspections were not performed
Four LIFEPAK 15 defibrillators are recalled because required inspections were not performed on units that had gone through servicing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the issue is a missed post-service inspection step rather than a defect found in the devices.
Plain-English summary
LIFEPAK 15 defibrillators are being recalled under part numbers V15-7-000022, V15-2-000051, V15-2-000099 and V15-2-001603, with corresponding catalog and UDI-DI codes and serial numbers listed in the recall notice. The recall covers 4 units, with distribution in Colorado and Montana.
The recall was issued because required inspections were not performed on products or units that had gone through servicing. The FDA classified the action as Class II. The notice does not describe a defect found in the devices.
Holders of affected units should follow the manufacturer's instructions for inspection or replacement.
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…
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 4
Distribution
Part of a larger recall action
This product is one of 3 recalled by Physio-Control, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Physio-Control, Inc.
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