Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Reported: February 26, 2020 Initiated: September 10, 2019 #Z-1271-2020
Product Description
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Reason for Recall
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
Details
- Recalling Firm
- Philips North America LLC
- Units Affected
- 44 units
- Distribution
- HeartStart FRx: US - CA, CT, FL, IL, MO, NY,TN, TX and WI OUS - Australia, Brazil, Canada, Germany, Italy, Japan, South Korea, Norway, Switzerland and Taiwan. HeartStart HS1: US - CT, FL, IL, MI, MS, NJ, TN, TX, WA and WI OUS - Argentina, Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Netherlands, Norway, Spain, Sweden, and Taiwan
- Location
- Bothell, WA
Frequently Asked Questions
What product was recalled? ▼
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017. Recalled by Philips North America LLC. Units affected: 44 units.
Why was this product recalled? ▼
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2020. Severity: Moderate. Recall number: Z-1271-2020.
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