Reported Feb 26, 2020 · Terminated
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
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 HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304
- HSI codeRevE.03.063
- Lot codes and dates
- HeartSmart HS1 Onsite ModelM5066A
- Software VersionFRx
- codeRevE.03.063
- System Serial Numbers
96 of 96 codes
A18B-01564A18B-05110A15F-00203A15F-00836A16A-05193A18B-01898A18B-04580A18C-06368A18C-13087A14J-05349A17G-04454A16F-05540A16H-00179A16I-05335A15C-06311A18B-01163A14E-01309A14H-00385A14H-03858A14J-06953A15B-02135A15I-00313A15J-02119A15J-03499A16A-00020A16A-04110A16D-02839A16E-00092A16E-00321A16E-01139A16H-01715A16H-03269A16H-03289A16H-03295A16H-03388A16I-01108A16I-01192A16J-03827A16K-09220A16K-09284A16K-09350A16L-08039A17D-02967A17E-06623A17L-05540A18B-06555A16B-01360A16J-04476A16F-05541A16K-06215A17F-05535A17G-01106A18B-05091A16L-03891A18D-00634A14I-05831A14I-06556A14J-04548A15H-01226A15H-04421
- Amount recalled
- Total 96 units = 95 units (HS1 Onsite) and 1 unit (HS1 Home)
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.
Want the full recall guide?
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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