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

Recall Z-2500-2021 — Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 113

U.S. FDA — Device Enforcement · United States · 2021-08-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2500-2021
Date of alert
2021-08-18
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)
11061610
Reported risk: Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in diagnosis or scan aborts with the necessity for patient rescan may occur
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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