Reported Feb 26, 2020 · Terminated
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America LLC · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- Philips HeartStart FRx AED, Model 861304
- FRx codeRevE.02.017
- Lot codes and dates
- Model861304
- Software VersionFRx
- codeRevE.02.017
- System Serial Numbers
B17G-05063B17C-03662B17D-00167B16G-06056B16J-03182B16J-03349B14J-00603B15E-08588B15G-03528B16A-00186B16A-00189B16A-00235B16J-01934B17G-02322B17G-02937B17I-00135B18E-01082B16L-03105B15L-01146B14H-00561B17D-00056B18E-01975B16K-02837B16E-01325B16E-01627B15E-06814B15L-07200B16K-03381B13G-04020B17F-02048B17I-08789B14I-00249B15G-02703B16E-01403B16E-00725B16F-04894B16J-06377B16G-05481B16K-03980B17F-07414B17H-05164B17I-07486B16C-00187B17D-00228
- Amount recalled
- 44 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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