Recall Z-2440-2019— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2440-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-25

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2019-07-25, terminated 2022-12-29. It names 3 FDA 510(k) clearances: K190578, K143400, K143401. Product: syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603. Reason: SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-07-25
Terminated: 2022-12-29
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

3 on FDA's record

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

syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603

Reason for recall

SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans

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