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

Recall Z-1343-2020 — Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,

U.S. FDA — Device Enforcement · United States · 2020-01-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1343-2020
Date of alert
2020-01-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hologic, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
81002143175
Reported risk: 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.
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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