Philips HeartStart AEDs Recalled for Quality Standards Defect
Philips is recalling 96 HeartStart AEDs because their Printed Circuit Assemblies were not manufactured or repaired to quality standards.
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 source explicitly identifies the recall as FDA Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly given the critical nature of the medical device involved.
Plain-English summary
Philips North America LLC is recalling 96 units of the Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) Automated External Defibrillators (AEDs). The recall involves 95 HS1 Onsite units and 1 HS1 Home unit, all identified by Model 861304 and HSI codeRev: E.03.063.
The affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured or repaired in accordance with quality standards. This defect is classified as an FDA Class II recall, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The devices were distributed in the United States (CA, CT, FL, IL, MI, MS, MO, NJ, NY, TN, TX, WA, WI) and internationally (Argentina, Australia, Brazil, Canada, France, Germany, Hong Kong, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, and Taiwan). Consumers and facilities should check their device serial numbers against the list provided by the FDA and contact Philips for instructions on repair or replacement.
The recalled product
- Product
- Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
- Manufacturer
- Philips North America LLC
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips North America LLC 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.
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