Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Keypad Oxidation
Physio-Control is recalling 29,952 LIFEPAK 15 Monitor/Defibrillators worldwide because oxidation on the keypad may prevent the device from delivering a shock.
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 3/5 (High).
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: The recall involves a critical medical device that may fail to deliver a life-saving shock, representing a significant risk of harm, but the source text does not report any specific injuries or fatalities, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Physio-Control, Inc. is recalling 29,952 units of the LIFEPAK 15 Monitor/Defibrillator. The recall affects devices that were either manufactured with or received an upgrade kit containing an affected keypad. The issue is caused by oxidation that has formed over time within the "Shock" button on the keypad.
The hazard is that the monitor/defibrillator may not deliver a shock after the "Shock" button is pressed. This failure could occur during a medical emergency when the device is needed to treat a patient.
The affected devices were distributed worldwide, including in the United States and numerous foreign countries. Consumers and healthcare facilities should check their serial numbers against the list provided by the manufacturer and contact Physio-Control for instructions on how to resolve the issue.
The recalled product
- Product
- LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
- Manufacturer
- Physio-Control, Inc.
- Affected units
- 29,952
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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