Siemens Medical Solutions USA, Inc Recall 91383
Description: Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Siemens Medical Solutions USA, Inc Recall 91383 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1002-2023 |
| Event ID | 91383 |
| Event Description | Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max |
| Product Type | Devices |
| Distribution | Worldwide distribution |
| Quantity | 886 units |
| Recall Reason | There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations. |
| Device Classification | 20230125 |
| Device Code Info | All serial numbers 1) Luminos Agile Max, Material #10762472, UDI/DI: 4056869009162 2) Luminos drF Max, Material #10762471, UDI/DI: 4056869009155 3) Luminos Lotus Max, Material #11574100, UDI/DI: 4056869269331 |
| Center Classification Date | 20230119 |
| Recall Initiation Date | 20221209 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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