Z-2440-2019 Class II Terminated
FDA device recall Z-2440-2019 was initiated by Siemens Medical Solutions USA, Inc on July 25, 2019 and is designated Class II. 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 notif… The recall status is terminated (terminated December 29, 2022). Affected quantity: 2867 units worldwide (OUS); 1464 units US.
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2019
- Initiation Date
- July 25, 2019
- Termination Date
- December 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2867 units worldwide (OUS); 1464 units US
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
Distribution Pattern
Nationwide Foreign:
Code Information
syngo.CT software version VA48A_SP5.5