Z-0771-2021 Class II Terminated
FDA device recall Z-0771-2021 was initiated by Siemens Medical Solutions USA, Inc on November 24, 2020 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated February 6, 2024). Affected quantity: 3044.
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- November 24, 2020
- Termination Date
- February 6, 2024
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 3044
Product Description
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Reason for Recall
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
Distribution Pattern
US Nationwide
Code Information
SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000) Siemens SOMATOM CT scanner systems with software syngo.CT VB20A_SP2.