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

Recall Z-0474-2022 — SOMATOM Edge Plus-Computed tomography system Model 1026700

U.S. FDA — Device Enforcement · United States · 2021-11-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0474-2022
Date of alert
2021-11-19
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)
04056869006949
Reported risk: Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
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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