Z-1253-2021 Class II Terminated
FDA device recall Z-1253-2021 was initiated by Siemens Medical Solutions USA, Inc on March 3, 2021 and is designated Class II. Reason for recall: SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in … The recall status is terminated (terminated December 28, 2023). Affected quantity: 190 units US.
Recall Details
- Product Type
- Devices
- Report Date
- March 24, 2021
- Initiation Date
- March 3, 2021
- Termination Date
- December 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 units US
Product Description
Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model 11061670) SOMATOM X.cite (Model 11330001)
Reason for Recall
SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result
Distribution Pattern
US Nationwide distribution.
Code Information
Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a