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

Recall Z-1694-2013 — Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography

U.S. FDA — Device Enforcement · United States · 2013-02-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1694-2013
Date of alert
2013-02-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10140000
Reported risk: Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility is rare, the system could move while a patient's breast is compressed resulting in a possible bruise. Firm released Update Instructions XP031/12/S for this iss
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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