Philips Recalls HeartStart Home and OnSite AEDs Due to Solder Residue
Philips is recalling HeartStart Home and OnSite AEDs because solder residue may prevent the device from delivering therapy in an emergency.
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 medical device potentially failing to deliver therapy during a cardiac arrest, which represents a risk of harm where injury has not yet been reported.
Plain-English summary
Philips Medical Systems North America Inc. is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). The affected models are M5066A, M5067A, and M5068A. A total of 5,075 units are involved in this recall, with 2,724 units distributed in the United States and 2,351 units distributed outside the US.
The recall is being issued because one or both contact pins on the devices may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact occurs, the device may be unable to deliver therapy in an emergency.
Consumers should check the serial number of their device against the list of affected units provided by the FDA. If the device is affected, users should follow the instructions provided by Philips for repair or replacement to ensure the device functions correctly in an emergency.
The recalled product
- Product
- Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the
- Manufacturer
- Philips Medical Systems North America Inc.
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)
- SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA: A13G-00001
- A13G-00002
- A13G-00003
- A13G-00004
- A13G-00005
- A13G-00006
- A13G-00007
- A13G-00008
- A13G-00009
- A13G-00010
- A13G-00011
- A13G-00012
- A13G-00013
- A13G-00014
- A13G-00015
- A13G-00016
- A13G-00017
- A13G-00018
- A13G-00019
- A13G-00020
Distribution
Distributed nationwide across the United States.
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