Use cautionMedical device recall · FDA · Published January 16, 2023
Hologic 3D Medical C-Arm Recalls: Risk of Uncontrolled Movement Causing Injury
Hologic recalls specific models of 3D medical C-Arms due to risk of unexpected movement causing blunt trauma. Affected units include RM-SDM-00001-3D and other models with serial numbers listed. Contact Hologic for details.
“Hologic 3D Medical C-Arm Recalls: Risk of Uncontrolled Movement Causing Injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59029-hologic-3d-medical-c-arm-recalls-risk-of-uncontrolled-movement. Based on FDA recall #Z-1144-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1144-2023%22&limit=1).
The FDA announced on Jan. 16, 2023, that Hologic, Inc. is recalling its 3Dimensions and Selenia Dimensions C-arm devices due to unexpected movement that may cause blunt trauma. The recall affects 797 units distributed nationwide in the U.S.
Serial Numbers: 81001090068 through 81012167702 (inclusive list provided in record)
Units Affected: 797
The hazard
According to the FDA, the C-Arm may experience unexpected movement. If the tube arm impinges upon an individual, this movement may cause blunt trauma.
Context
GovInfoNow's records show Hologic, Inc. has 30 other recalls on record since 2017-06-27. Recent Hologic recalls include a 2026-04-08 recall of 3D Mammography Systems for loose bolts risk and a 2026-03-23 recall of Genius Review Station Displays for user modification risks. Other recent recalls of similar products include Merit Medical Custom Procedure Kit Recall (Handle May Detach During Use) (2025-12-04), Medtronic Bio-Medicus Adult Cannula Kit Recall (Loose Foreign Material Risk) (2026-05-25), and Medline medical convenience kits recall (Risk of syringe rotating adaptor unwinding during use) (2026-02-27).
How to tell if you have this one
Check for the model numbers listed in the recall: RM-SDM-00001-3D, SDM-00001-2D, SDM-05000-3D3, and others. Serial numbers starting with 810011 or similar patterns are also affected.
Brand
Hologic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify your C-Arm model by checking the product name or serial number on the device.
Contact Hologic
Reach out to Hologic directly for assistance with the recall and to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1144-2023 (January 16, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1144-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.