Recall Z-2735-2017 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
AGFA Healthcare Corp.
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
| Date | Dec 21, 2016 |
| Status | Terminated |
| Reason | A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS. |
| Root cause | Device Design |
| Action | On December 22, 2016, an URGENT FIELD SAFETY NOTICE letter was sent either by mail or email. The letter included an acknowledgement form to be returned. The letter informed the customer of the problem and actions to be taken. |
| Quantity | 221 units |
| Distribution | AL, AZ, AR, CA, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WV and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090672 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS Agfa Healthcare N.V., May 18, 2009 |