Philips HeartStart FRx AED Recalled for Potential Failure to Deliver Shock
Philips is recalling HeartStart FRx 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 involves a medical device that may fail to deliver a life-saving shock, posing a significant risk of serious injury or death.
Plain-English summary
Philips Electronics North America Corp. is recalling Philips HeartStart FRx AEDs. The recall involves a total of 660,519 defibrillators, including units for the FRx and HS1 models. These devices were manufactured between September 2002 and February 2013.
The recall is due to an issue with a specific electric component, a resistor, which could result in the device not delivering a shock when needed. The affected units were distributed nationwide, to Puerto Rico, and to various government and military entities. Foreign distribution included numerous countries across multiple continents.
Consumers should check the serial number on the back of the AED to determine if their device is affected. For Home/Onsite units, the serial number range is A02x-xxxxx through A13B-xxxxx. For FRx units, the range is B04x-xxxxx through B13B-xxxxx. Devices manufactured in 2013 with a 4th digit of 'C' or later (D, E, F, etc.) 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 FRx 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
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