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

Recall Z-1518-2016 — Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.

U.S. FDA — Device Enforcement · United States · 2016-03-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1518-2016
Date of alert
2016-03-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Reported risk: Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.
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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