Recall Z-0283-2022— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0283-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-30

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2021-08-30, terminated 2024-01-16. It names one FDA 510(k) clearance: K190578. Product: SOMATOM Force with software syngo.CT VB20 Model #10742326. Reason: software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2021-08-30
Terminated: 2024-01-16
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K190578 — SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM ConfidenceSiemens Medical Solutions USA, Inc.·cleared 2019-06-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SOMATOM Force with software syngo.CT VB20 Model #10742326

Reason for recall

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Data sourced from openFDA. This site is unofficial and independent of the FDA.