Physio-Control Recalls LIFEPAK CR2 Defibrillators Due to Missing Lid Magnets
Physio-Control is recalling 89,763 LIFEPAK CR2 defibrillators because missing lid magnets may cause premature battery depletion.
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: The recall is classified as FDA Class II, and the hazard involves a functional defect (battery depletion) without reported injuries or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
Physio-Control, Inc. is recalling 89,763 units of the LIFEPAK CR2 defibrillator (Model 3321605-xxx). The recall is due to complaints that some units have missing lid magnets, which may result in premature battery depletion.
The affected devices are distributed worldwide, including across the United States and in numerous international markets. The LIFEPAK CR2 is a fully automatic defibrillator designed for indoor and outdoor use in stationary environments, indicated for patients one year of age or older in cardiopulmonary arrest.
Consumers and healthcare facilities should check their device serial numbers against the list provided by the manufacturer or the FDA to determine if their unit is affected. If a unit is affected, users should contact Physio-Control for instructions on repair or replacement.
The recalled product
- Product
- PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is…
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Hazard
- Affected units
- 89,763
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Model Number 3321605-xxx
- U.S. Device Part Numbers with Conforming Lids: CR2-2-001281
- CR2-2-001279
- CR2-2-001285
- CR2-2-001278
- CR2-2-001283
- CR2-2-001280
- CR2-2-001451
- CR2-2-001452
- CR2-2-000396
- CR2-2-001457
Distribution
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Similar recalls
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