Recall Z-2270-2019— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2270-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-03

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2019-07-03, terminated 2024-05-10. It names one FDA 510(k) clearance: K190578. Product: SOMATOM Definition Flash, Model Number 10430603 - 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).. Reason: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-07-03
Terminated: 2024-05-10
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 Definition Flash, Model Number 10430603 - 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).

Reason for recall

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

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