ZOLL AED PRO Defibrillators Recalled for Potential Energy Delivery Failure
ZOLL Medical Corporation is recalling 1,969 AED PRO units because they may fail to deliver energy to patients during cardiac arrest.
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. The hazard involves a life-saving device potentially failing to deliver energy during cardiac arrest, which poses a risk of harm, but no specific injuries or deaths are reported in the source text.
Plain-English summary
ZOLL Medical Corporation is recalling 1,969 units of the AED PRO Automated External Defibrillator. The recall was initiated because there is a potential for the device to fail to deliver energy to the patient. The AED PRO is intended for defibrillating victims of ventricular fibrillation or pulseless ventricular tachycardia, as well as for ECG and CPR monitoring.
The affected products were distributed worldwide, including nationwide in the United States and in 22 foreign countries such as Canada, Germany, Japan, and Australia. The recall includes specific part numbers, GTINs, and serial numbers listed in the official FDA record.
Consumers and healthcare facilities should check their AED PRO units against the provided serial numbers. If a unit is affected, it should be removed from service and returned to ZOLL Medical Corporation for repair or replacement.
The recalled product
- Product
- ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a m
- Manufacturer
- ZOLL Medical Corporation
- Category
- Medical Device — Defibrillator
- Affected units
- 1,969
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 (9)
- Part Numbers: 90010200499991010
- 90010400499991010
- 70010400499991010
- 90010202499991010
- 90010600499991010
- GTIN: 00847946016128
- 00847946016142
- 00847946015138
- 00847946016135
Distribution
Distributed nationwide across the United States.
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