LIFEPAK 1000 defibrillators recalled over inspections missed after unit servicing
Three LIFEPAK 1000 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 1000 defibrillators are being recalled under part numbers 320371500023, 320371500229 and 331706400001, catalog number 99425-000025, UDI-DI 885074698953, with serial numbers listed in the recall notice. The LIFEPAK 1000 is to be used in AED mode only. The recall covers 3 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 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…
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 3
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
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