Siemens Medical Solutions USA, Inc Recall 88820
Description: Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815
Siemens Medical Solutions USA, Inc Recall 88820 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0200-2022 |
| Event ID | 88820 |
| Event Description | Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 43 US |
| Recall Reason | Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient |
| Device Classification | 20211110 |
| Device Code Info | Artis zeego systems with Artis patient table and AppSW VD20C/VD20N |
| Center Classification Date | 20211104 |
| Recall Initiation Date | 20210924 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
| Similar To |