Reported Jun 11, 2014 · Terminated
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full…
Hologic, Inc.
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: Hologic, Inc. · 36 Apple Ridge Rd # 37 · Danbury, CT · 06810-7301
Is this the product you have?
- Hologic Selenia
- Full Field Digital Mammography SystemSEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer
- Lot codes and dates
- Serial Numbers
2840314W80652840314W8062W2840314W8066W2840314W8067 2840314W80732840314W80642840314W8056W28401082720 2840708357928401137611W28403083045W
- Serial Numbers
- Amount recalled
- 11 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
Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
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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