Recall Z-2137-2011 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
AGFA Corp.
NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for the radiographer throughout the imaging process. NX communicates seamlessly with the hospi
| Date | May 4, 2011 (initiated Mar 4, 2011) |
| Status | Terminated |
| Reason | When a radiographer is working on two open studies on an NX workstation and, in specific situations, a problem of image/annotation mix-up can occur on the NX system. |
| Root cause | Other |
| Action | AGFA Corp. sent an "URGENT FIEL SAFETY NOTICE" letter via FED-EX to the customers on March 4, 2011. The letter describes the safety alert and mitigation. Customers were instructed to complete and return the Urgent Field Safety Notice Feedback Form by fax to 864-421-1664. For questions regarding this recall call 864-421-1815. |
| Quantity | 775 units |
| Distribution | Worldwide Distribution - USA including CA, GA, MS, ND, NM, NY, OK, PA, SC, SD, TX, and VA and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071162 | AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS Agfa Healthcare Corp., May 8, 2007 |