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Terminated

Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model 11061670) SOMATOM X.cite (Model 11330001)

FDA Recall Z-1253-2021 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2021-03-03
Date Terminated2023-12-28
Product Quantity190 units US

Reason for Recall

SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result

Firm Action

Siemens Medical Solutions USA, Inc., provided Customer Information Letter on 3/3/21 to affected customers via CT063/20/S. Customers with valid email addresses emailed a copy of the CSAN via Adobe Mega Sign. The CSAN will be distributed to the remaining customers address via hand delivery by the Siemens Customer Service Engineer. The letter states reason for recall, health risk and action to take: Siemens Healthineers has developed software update syngo.CT VA30A_SP3 to ensure uninterrupted scanning workflows and to reduce the number of user notifications. This update will also provide improvements related to the general system, examination and reconstruction processes, as well as improvements for dual energy post-processing. Following the corrective action, the cause has been eliminated and recurrence of the identified issues are prevented. This software update will be provided to you free of charge. How will the corrective action be implemented? Software update CT084/20/S will be performed onsite for SOMATOM X.cite (Model #11330001). For all other systems, the update CT064/20/S will be performed remotely. The remote software updates process will require approximately 180 minutes for completion. If you have any unresolved questions or you require technical support, please contact your local application specialists or your local service/sales organization at 1-800-888-7436.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200524SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GOSiemens Medical Solutions USA, Inc. · 2020-04-01K192061SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GOSiemens Medical Solutions USA, Inc. · 2019-11-21K173632SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc. · 2018-04-13K163296SOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc. · 2017-03-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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