FDA Recall
Terminated
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Recall: Z-0771-2021
·
Initiated November 24, 2020
Recall
- Recall Number
- Z-0771-2021
- Event Number
- 87079
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- JAK
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 24, 2020
- Terminated
- February 6, 2024
- Address
- 40 Liberty Blvd, Malvern, PA, 19355
Description
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Reason
System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan
Action
Customer notification letters will be sent starting December 14, 2020 to all affected customers via Customer Advisory Notice CT057/20/S. The technical solution, software versionVB20A_SP3, will be distributed to all affected customers free of charge via CT056/20/S. For questions or technical support, contact your local application specialists or your local service/sales organization at 1-800-888-7436.
Distribution
US Nationwide
Quantity
3044