Physio-Control Recalls LifePAK 500 AEDs Due to Contact Plating Wear
Physio-Control is recalling 173,459 LifePAK 500 AEDs because mechanical wear on the therapy connector may prevent the device from detecting a patient, potentially delaying treatment.
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 is classified as FDA Class II and involves a risk-of-harm product (AED) where a failure to detect a patient could delay treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Physio-Control, Inc. is recalling 173,459 units of the LifePAK 500 Automated External Defibrillator (AED). The affected model numbers are 3005400-XXX, U3005400-XXX, 3011790-XXX, and U3011790-XXX. The recall covers all lots and includes devices distributed worldwide, including across the United States and numerous international locations.
The recall is being conducted because mechanical wear-through of the contact plating on the therapy connector may cause the AED to fail to detect a patient connection. If the device does not recognize that a patient is connected, it may not indicate a shockable rhythm, which could result in a delay in treatment.
This is an FDA Class II recall. Users of the affected devices should contact Physio-Control for instructions on how to address the issue.
The recalled product
- Product
- LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s…
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 173,459
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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