Reported Mar 1, 2023 · Ongoing
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC…
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 · Danbury, CT · 06810-7301
Is this the product you have?
- Hologic 3Dimensions/Selenia
- Dimensions Models
RM-SDM-00001-3DSDM-00001-2DSDM-00001-3DSDM-05000-3D3SDM-05000-2DCSDM-00001-M3DSDM-05000-3DCSDM-SYS-6000-3DSDM-05000-2D3SDA-SYS-3000-2DSDM-00001SDM-SYS-9000-2DSDM-00001-M2D3DM-SYS-STD3DM-SYS-STD-NSSDM-05000-2ACSDM-05000-2A2SDA-SYS-3000-3DSDA-SYS-3000-3D-UPSSDM-SYS-6000-3D-HTCSDM-05000-2D2SDM-05000-3D2SDM-SYS-6000-2DSDM-SYS-9000-3D
- Lot codes and dates
- UDI15420045508019; 15420045505636 Serial Numbers;
802 of 802 codes
810010900688100110017781001110594810011106128100111062781001121279810011320518100113205781001132096810011429838100114299081001142995810011430358100114305181001143060810011430688100114307181001154286810011543098100115431081001154320810011543228100115434081001165989810011659978100116599981001166000810011660158100116607381001166090810011660948100116609881001166109810011661198100116612481001177755810011777598100117776481001177803810011778098100117781981001177820810011778228100117782681001177829810011778328100117784481001177851810011778538100210018981002100197810021106518100211066281002110663810021106648100212129181002121328810021321138100214309081002143092
- UDI15420045508019; 15420045505636 Serial Numbers;
- Amount recalled
- 797 units
Where it was sold
- Nationwide
Why it was recalled
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
This product could cause temporary or reversible health problems — stop using it.
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