Recall Z-0172-2014 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Artis zee systems x-ray, angiographic system
| Date | Nov 14, 2013 (initiated Jan 21, 2013) |
| Status | Terminated |
| Reason | The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur. |
| Root cause | Device Design |
| Action | Siemens sent an letter to all affected customers in January 2013, notifying them of the potential issue and urging customers to make appointments with Siemens to have software update AX 027/12/S realized in order to resolve the problem. The software update was made available from January 22, 2013, on. Customers were also asked to pass along this information if the device was no longer in their possession. The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 17 unit(s) will consist of the following: 1. The firm sent out a customer notification letter in Jan |
| Quantity | 17 |
| Distribution | US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090745 | ARTIS ZEE / ZEEGOS WITH SW VC14 Siemens Medical Solutions USA, Inc., Jun 18, 2009 |