FDA Enforcement
Class II
Terminated
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
Recall: Z-2440-2019
·
Reported September 11, 2019
Enforcement
- Recall Number
- Z-2440-2019
- Event ID
- 83519
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 11, 2019
- Initiation Date
- July 25, 2019
- Classification Date
- August 30, 2019
- Termination Date
- December 29, 2022
- Address
- 40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States
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
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
Code Info
syngo.CT software version VA48A_SP5.5
Distribution
Nationwide Foreign:
Quantity
2867 units worldwide (OUS); 1464 units US