Siemens Medical Solutions USA, Inc Recall 86985
Description: Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
Siemens Medical Solutions USA, Inc Recall 86985 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0805-2021 |
| Event ID | 86985 |
| Event Description | Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery). |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 6 |
| Recall Reason | After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time. |
| Device Classification | 20210120 |
| Device Code Info | Serial Nos. 3417 3414 3415 3418 3428 3416 |
| Center Classification Date | 20210108 |
| Recall Initiation Date | 20200909 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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