—#174996

Product

SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K103127
Affected lot / code info: Serial Numbers: 98474 92280 92261 65370 66032 66649 65299 92298 64516 92335 92300 66062 64218 92313 92296 92254 64051 92342 92277 92307 92336 92315 92288 98473 65145 65493 92323 92321 92243

Why it was recalled

Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

Root cause (FDA determination)

Software design

Action the firm took

Siemens has initiated a Customer Safety Advisory Notice (CSAN) to all affected customers via CT035/19/S. Customers with valid email addresses were emailed a copy of the CSAN on 07/03/2019 via Adobe Mega Sign. The CSAN were distributed to the remaining customers without a valid email address via certified mail on 07/12/2019. Additionally, a solution to eliminate the root cause of this problem (application of software update VB20) will be distributed to all affected customers free of charge. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2019-07-03
Terminated: 2024-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174996. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.