Hologic Mammography Systems Recalled for Unexpected C-Arm Movement
Hologic is recalling 797 units of its 3Dimensions/Selenia Dimensions mammography systems nationwide due to unexpected C-arm movement that may cause blunt trauma.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported injuries or illnesses mentioned in the source. The hazard represents a risk-of-harm product where injury has not yet been reported. Under the severity rubric, potential injury hazards without reported illness meet the threshold for Score 3 (High).
Plain-English summary
Hologic, Inc. is recalling 3Dimensions/Selenia Dimensions mammography systems. The recall affects 797 units distributed nationwide.
The C-arm may move unexpectedly. Should the tube arm contact an individual during this unexpected movement, it may cause blunt trauma.
These systems are used in medical imaging facilities for breast imaging procedures. The recall covers multiple system models across the SDM and 3DM product lines.
The FDA classified this as a Class II recall to address the safety hazard identified with unexpected C-arm movement.
The recalled product
- Product
- Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS…
- Manufacturer
- Hologic, Inc.
- Affected units
- 797
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 15420045508019
- 15420045505636 Serial Numbers
Distribution
Distributed nationwide across the United States.
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