Recall Z-1495-2021 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
| Date | Mar 26, 2021 |
| Status | Open, Classified |
| Reason | Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system. |
| Root cause | Device Design |
| Action | Siemens issued Urgent Medical Device Correction letter dated March 26, 2021. Letter states reason for recall, health risk and action to take: Siemens will inspect the potentially affected area and will install an additional cover to improve the cable guidance and prevent further cable harness damage via Update Instruction AX008/20/S. If damage caused by abrasion is too severe, the cable harness will be replaced via Update Instruction AX011/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organiz |
| Quantity | 772 units U.S. |
| Distribution | Nationwide |
| 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 |