Reported May 30, 2018 · Terminated
Philips HeartStart (HS1) Onsite/Home AED
Philips Electronics North America Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Electronics North America Corp. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- Philips HeartStart (HS1) Onsite/Home AED
- Lot codes and dates
- Manufactured between September 2002 and February 2013. The year of manufacture can be identified by the 2nd and 3rd characters in the serial number on the
- back of the AED in the following rangesHome/Onsite: A02x-xxxxx through A13B-xxxxx
- FRxB04x-xxxxx
- through B13B-xxxxx NOTEIf the device was manufactured in 2013 and the 4th digit is the letter "C" or later (D, E, F...), it is not covered by the recall (i.e. A13G-02375). In some cases, a device within the date range covered by the notification did not contain a resistor previously associated with a failure. In that case, a notification was not sent. Confirmation as to whether the device contains the resistor at issue can be done by contacting the firm
- Amount recalled
- Total for FRx and HS1 - 660,519 defibrillators
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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