Recall Z-2888-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Cios Spin, Image-Intensified Fluoroscopic X-Ray System The 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 | Jul 30, 2020 |
| Status | Terminated |
| Reason | Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU). |
| Root cause | Device Design |
| Action | Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 27, 2020 to customers. This letter explains the issue that may arise while using the system. The letter instructs users to NOT disconnect the main unit from the monitor trolley when the system displays the system error message Err 16305 / 80: Confirm this error and repeat your last action to avoid potential electrical shock until pending hardware update has been completed. Our service organization will contact you for an appointment to perform the corrective action. Please feel free to contact our service organization at 1-8 |
| Quantity | 329 units in total |
| Distribution | US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181550 | Cios Spin Siemens Medical Solutions USA, Inc., Oct 30, 2018 |