Siemens Medical Solutions USA, Inc Recall 87079
Description: SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Siemens Medical Solutions USA, Inc Recall 87079 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-0771-2021 |
| Event ID | 87079 |
| Event Description | SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus |
| Product Type | Devices |
| Distribution | US Nationwide |
| Quantity | 3044 |
| Recall 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 |
| Device Classification | 20210120 |
| Device Code Info | 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. |
| Center Classification Date | 20210109 |
| Recall Initiation Date | 20201124 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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