Recall Z-0854-2015 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipur
| Date | Jan 14, 2015 (initiated Sep 17, 2014) |
| Status | Terminated |
| Reason | The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed, resulting in a short interruption of the procedure. |
| Root cause | Process control |
| Action | Planned action (s) to repair defect or to bring product into compliance for Siemens Medical Solutions Inc. concerning the corrective action plan (CAP) for the Model(s) Artis Zee/Zeego Stationary Angiographic X-ray Systems. 1.Notifying the customer of the defect. 2.Implementing a corrective software patch to protect the system from damage in the event of hardware failure 3. Scheduling a service visit from a Siemens representative to perform a hardware replacement. 4. Replacing the non-conforming X-ray tube with one manufactured after the nonconformity issue was resolved. For further questi |
| Quantity | 44 |
| Distribution | USA Distribution to the states of MO, MI, NY, OK, CA, LA, CT, IN, VA, MD, WA, HI, ME, TX, NY, OH, PA and CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073290 | ARTIS ZEE AND ZEEGO Siemens Medical Solutions USA, Inc., Feb 11, 2008 |