Recall Z-2569-2014 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Artis zee and Artis zeego systems. x-ray, angiographic system
| Date | Sep 22, 2014 (initiated Jun 5, 2014) |
| Status | Terminated |
| Reason | There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can become blocked unnecessarily. |
| Root cause | Software design |
| Action | Siemens sent an "Important Customer Safety Notice" dated August 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please forward this Safety information to other organizations that could be affected by this measure. If the device has been sold and therefore no longer in your possession, please forward this safety notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this Customer Safety Notice and comply with the correspondi |
| Quantity | 206 |
| Distribution | Nationwide Distribution |
| 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 |