Recall Z-0200-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
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
| Date | Sep 24, 2021 |
| Status | Open, Classified |
| 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 |
| Root cause | Software design |
| Action | Siemens Healthineers issued Urgent Medical Device Correction Letter (AX059/21/S) dated 9/24/21. Letter states reason for recall, health risk and action to take: To avoid possible incorrect patient treatment, Siemens recommends a working position with 0 degree table rotation be used if intraoperative 3D images are required for subsequent steps (e.g., image superimposition, C-arm positioning, laser cross). If it should still be necessary to use a table rotation other than 0 degrees for intraoperative 3D images, please verify the C-arm position, needle position and image superimposition, by mean |
| Quantity | 43 US |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181407 | Artis zee/zeego & Artis Q/Q.zen Siemens Medical Solution USA, Inc., Aug 15, 2018 |