Physio Control Recalls LIFEPAK 500 AEDs Due to Assembly Error
Physio Control is recalling 139 LIFEPAK 500 AEDs because an assembly error could cause internal shorting, rendering the device inoperable.
What this means for you
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 the hazard involves a life-saving medical device that could become inoperable, posing a risk of harm without reported injuries.
Plain-English summary
Physio Control, Inc. is recalling 139 units of the LIFEPAK 500 Automated External Defibrillator (AED). The recall involves 125 units in the United States and 14 units outside the US. The devices were distributed nationwide in the US, including in Illinois, Massachusetts, North Carolina, North Dakota, New York, Pennsylvania, Rhode Island, Texas, Washington, and Wisconsin, as well as in Canada.
The recall is due to an assembly error that could cause internal shorting on a printed circuit board assembly. If affected, this malfunction could render the device inoperable. The LIFEPAK 500 AED is a semi-automatic defibrillator intended for use by authorized personnel in pre-hospital, workplace, and community environments.
Consumers and healthcare facilities should check their device serial numbers against the list provided in the official recall notice. Affected units should be removed from service and returned to Physio Control for repair or replacement.
The recalled product
- Product
- The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIF
- Manufacturer
- Physio Control, Inc.
- Category
- Medical Device — Defibrillator
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 (20)
- PART NUMBERS: 3011790-001568
- 3011790-001574
- 3011790-001627
- 3011790-001634
- and 3011790-001650. SERIAL NUMBERS OUTSIDE the US: 41232265
- 41232267
- 41232269
- 41232270
- 41232271
- 41232272
- 41238207
- 41238208
- 41301145
- 41301370
- 41301371
- 41301372
- 41301373
- and 41301374. SERIAL NUMBERS IN THE US: 41134905
- 41134906
- 41134907
Distribution
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