Recall Z-1954-2019 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Cios care fusion system
| Date | Jun 20, 2019 |
| Status | Terminated |
| Reason | DAP chamber may be missing an insulating foil |
| Root cause | Nonconforming Material/Component |
| Action | 1. Siemens will inspect the DAP chamber on your unit, and if necessary, replace it with insulated DAP chamber. 2. Siemens service organization will contact you shortly to arrange a date to perform this corrective action. 3. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. |
| Quantity | 1 |
| Distribution | IL, NE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153244 | Cios Fusion Siemens Medical Solutions USA, Inc., Mar 7, 2016 |