Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems
FDA device recall Z-0854-2015 · posted 2015-01-14 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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 questions please call (610) 219-6300.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 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.
- Date initiated
- 2014-09-17
- Date posted
- 2015-01-14
- Date terminated
- 2015-08-06
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ZEE AND ZEEGO (K073290) | Siemens Medical Solutions USA, Inc. | 2008-02-11 |