Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition

FDA device recall Z-3025-2020 · posted 2020-09-28 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan

Action taken

Siemens Medical Solutions USA, Inc. has initiated a Customer Information Letter (CIL) to affected customers via CT004/20/S. The letter alerts customers of the technical issues and under what circumstances they may occur and health risk These issues will be resolved with software update version syngo CT VB20_SP2 (Service Pack 2) via UI CT003/20/S. The software update is being made available to all affected customers free of charge. If your system is connected to Siemens Remote Connection, this update will be performed remotely. The remote software update process will require approximately 2 hours for completion and is completely automatic; however, please make sure the system and power are stable before and during the process, please do not switch off the system during the update process. Siemens highly recommends starting the installation when the scanner will not be in use or when the necessary time for the update to be completed can be scheduled. your system is not connected to the Siemens Remote Connection, your Siemens Customer Service Engineer will schedule an appointment to perform the software update onsite. If you have any questions, please contact our service organization at 1-800-888-7436.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

767 distributed in U.S.

Distribution

Nationwide

Date initiated

2020-06-22

Date posted

2020-09-28

Date terminated

2021-03-09

Location

Malvern, PA

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