Defibrillator recalled because required post-service inspections were not performed
One LIFEPAK CR2 defibrillator is 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 device.
Plain-English summary
The LIFEPAK CR2 defibrillator, part number CR2-2-001451, catalog number 99512-001434, UDI-DI 883873785911, serial number 49638156, is being recalled. The LIFEPAK CR2 is indicated for use on patients one year of age or older in cardiopulmonary arrest. The recall covers 1 unit, 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 device.
The holder of the affected unit should follow the manufacturer's instructions for inspection or replacement.
The recalled product
- Product
- LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not…
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 1
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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