Philips HeartStart FR3 Defibrillators Recalled for Water Ingress Risk
Philips is recalling 432 HeartStart FR3 defibrillators because they may not meet water resistance specifications, potentially causing device failure if water enters.
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 involves a life-saving medical device that may fail to function due to water ingress. This is a risk-of-harm product where injury or death could result from device failure during a cardiac arrest, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Electronics North America Corp. is recalling 432 units of the HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The recall is due to a defect where the devices may not fully meet the IPx5 water ingress specification. If water intrusion occurs, the device may fail to function.
The affected devices were distributed nationwide in the United States, specifically in Georgia, Missouri, Indiana, Florida, New York, Hawaii, California, Louisiana, Washington, Illinois, and Nebraska. They were also distributed in foreign countries including Australia, Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Kazakhstan, Netherlands, Norway, Spain, Switzerland, Taiwan, and the United Kingdom. Affected serial numbers begin with C16J, C16K, C17A, or C17B.
Consumers should check the serial number of their device against the list provided by the manufacturer. If the device is affected, users should contact Philips for instructions on repair or replacement. The device is intended for use on adults and children over 55 pounds or 8 years old, and for younger children when used with the optional Infant/Child Key.
The recalled product
- Product
- Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are
- Manufacturer
- Philips Electronics North America Corp.
- Affected units
- 432
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 (3)
- Serial Numbers of affected AEDs begin with C16J
- C16K
- C17A
Distribution
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