Philips HeartStart FRx AED Recalled for Quality Standards Violation
Philips is recalling 44 HeartStart FRx AED units because their Printed Circuit Assemblies were not manufactured or repaired according 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 3/5 (High).
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 medical device (AED) where quality standards were not met, representing a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Philips North America LLC is recalling 44 units of the Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017. The recall is due to a defect in the Printed Circuit Assembly (PCA), which was not manufactured or repaired in accordance with quality standards.
The affected devices were distributed in the United States (CA, CT, FL, IL, MO, NY, TN, TX, and WI) and internationally (Australia, Brazil, Canada, Germany, Italy, Japan, South Korea, Norway, Switzerland, and Taiwan). The source text also lists distribution data for the HeartStart HS1 model, but the specific recall notice provided focuses on the HeartStart FRx AED.
Consumers should check their device's system serial number against the list of 44 affected units provided in the official recall notice. If the serial number matches, users should contact Philips North America LLC for instructions on repair or replacement.
The recalled product
- Product
- Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
- Manufacturer
- Philips North America LLC
- Affected units
- 44
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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