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

Recall Z-0962-2022 — SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM

U.S. FDA — Device Enforcement · United States · 2022-03-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0962-2022
Date of alert
2022-03-07
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)
04056869051291
Reported risk: Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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