Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1144-2023 — 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 SDM-05000-2AC SDM-05000

U.S. FDA — Device Enforcement · United States · 2023-01-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1144-2023
Date of alert
2023-01-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hologic, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15420045508019
Reported risk: C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.