LIFEPAK 20e Defibrillator Recalled for Incorrect Keypad Installation
Physio-Control is recalling LIFEPAK 20e defibrillator/monitor units distributed in West Virginia due to incorrect keypad installation during manufacturing. The keypad error may affect device operation.
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: This is an FDA Class II recall for a manufacturing defect (incorrect keypad installation) on a life-critical cardiac device. No reported injuries or deaths are documented. Per the rubric, recalls with no reported harm where the hazard presents risk-of-harm to a critical device score a maximum of 3 (High).
Plain-English summary
Physio-Control, Inc. is recalling the LIFEPAK 20e defibrillator/monitor (Model 99507-000001) due to an incorrect keypad that was installed during manufacturing. The affected units were distributed in West Virginia.
An incorrect keypad installation on this cardiac medical device raises concerns about proper function and operation when needed for patient care in emergency situations.
Owners of the affected defibrillator should contact Physio-Control, Inc. for repair, replacement, or further instructions. The device should be checked and verified to ensure proper operation before continued use.
The recalled product
- Product
- LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
- Manufacturer
- Physio-Control, Inc.
- Affected units
- 1
Distribution
Distributed in 1 state:
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