Philips HeartStart AED Recall for Potential Failure to Deliver Shock
Philips is recalling HeartStart AEDs because a resistor issue may prevent the device from delivering a shock when needed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device failing to deliver a life-saving shock, which constitutes a significant injury risk.
Plain-English summary
Philips Electronics North America Corp. is recalling the Philips HeartStart (HS1) Onsite/Home AED. The recall covers a total of 660,519 defibrillators, including both FRx and HS1 models. These devices were manufactured between September 2002 and February 2013.
The recall is being conducted because an issue with one of the electric components, specifically a resistor, could result in the device not delivering a shock when needed. This failure mode poses a risk to patients who may require emergency defibrillation.
The affected devices were distributed nationwide in the United States, to Puerto Rico, and to government and military entities. Foreign distribution included numerous countries across the globe. Consumers and healthcare providers should check the serial number on the back of the AED to determine if their device is covered. The year of manufacture is identified by the 2nd and 3rd characters in the serial number. Home/Onsite units are covered if the serial number ranges from A02x-xxxxx through A13B-xxxxx, and FRx units are covered if the serial number ranges from B04x-xxxxx through B13B-xxxxx. Devices manufactured in 2013 with a 4th digit of 'C' or later are not covered. Users can contact the firm to confirm if their specific device contains the resistor at issue.
The recalled product
- Product
- Philips HeartStart (HS1) Onsite/Home AED
- Manufacturer
- Philips Electronics North America Corp.
- 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 (3)
- E
- F...)
- it is not covered by the recall (i.e. A13G-02375). In some cases
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips Electronics North America Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Philips Electronics North America Corp.
See all →- HighPhilips HeartStart FR3 Defibrillators Recalled for Water Ingress Risk
FDA (Devices) · 2018-10-24
- SeverePhilips HeartStart FRx AED Recalled for Potential Failure to Deliver Shock
FDA (Devices) · 2018-05-30
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Similar recalls
- SeverePhilips HeartStart AEDs Recalled for Quality Standards Defect
FDA (Devices) · 2020-02-26
- ModeratePhilips HeartStart HS1 Defibrillators Recalled for Manual Clarification
FDA (Devices) · 2013-01-16
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