Recall Z-1295-2019 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurolo
| Date | Mar 22, 2019 |
| Status | Terminated |
| Reason | Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists |
| Root cause | Device Design |
| Action | Siemens issued Customer Safety Advisory Letter dated 3/22/19 advising of problem, health risk and action to take: recommends to avoid overwriting the organ programs, as this can lead to frequent operations. Siemens is distributing this letter and the addendum to the user manual to all potentially affected users Contact our service organization for any additional questions at 1-800-888-7436. |
| Quantity | 2 US |
| Distribution | US Nationwide Distribution in the states of NC, MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181560 | Cios Alpha Siemens Medical Systems USA, Inc., Oct 24, 2018 |