Recall Z-2848-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
| Date | Aug 22, 2020 (initiated Jul 14, 2020) |
| Status | Terminated |
| Reason | Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging functionality. |
| Root cause | Device Design |
| Action | Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to affected customers via AX013/20/S dated July 14, 2020, The letter states reason for recall, health risk and action to take: We advise urgently to cease the use of the hot plugging feature until the pending hardware update AX014/20/S has been completed. Siemens will correct the hardware error via Update Instruction AX014/20/S in which a Siemens Service Engineer will replace the main control D80. Service organization will contact you shortly to arrange a date to performthis corrective action. Please feel free to |
| Quantity | US: 282 units; OUS: 1363 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |