Siemens Medical Solutions USA, Inc Recall 92229
Description: Luminos Agile Max (VE10, VF10, VF11)
Siemens Medical Solutions USA, Inc Recall 92229 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-1479-2023 |
| Event ID | 92229 |
| Event Description | Luminos Agile Max (VE10, VF10, VF11) |
| Product Type | Devices |
| Distribution | US Nationwide - Worldwide Distribution |
| Quantity | 704 units in the United States (1945 units worldwide) |
| Recall Reason | Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation. |
| Device Classification | 20230531 |
| Device Code Info | Model: 10762472 |
| Center Classification Date | 20230523 |
| Recall Initiation Date | 20221123 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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