Reported Mar 4, 2020 · Terminated
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
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 and 37 Apple Ridge Rd · Danbury, CT · 06810-7301
Is this the product you have?
- Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
- Lot codes and dates
- Serial Numbers
72 of 72 codes
8100214317581002143176810021431778100314317881003143179810031431808100314318181003143182810031431838100314318481003143185810031431868100314318781003143188810031431898100314319081003143191810031431928100314319381003143194810031431958100314319681003143197810031431988100314319981003143200810031432018100314320281003143203810031432048100314320581003143206810031432078100314320881003143209810031432108100314321181003143212810031432138100314321481003143215810031432168100314321781003143218810031432198100314322081003143221A81003143222A8100314322381003143224A81003143225810031432268100314322781003143228810031432298100314323081003143231810031432328100314323481003143235
- Serial Numbers
- Amount recalled
- 72
Where it was sold
Why it was recalled
The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.
This product could cause temporary or reversible health problems — stop using it.
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