Recall Z-2100-2010 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
AGFA Corp.
19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.
| Date | Jul 26, 2010 (initiated Jun 30, 2010) |
| Status | Terminated |
| Reason | Monitor fell from the mounting bracket used to support the monitor. |
| Root cause | Other |
| Action | The firm, AGFA Healthcare sent an 'URGENT SAFETY NOTICE" dated June 30, 2010, via FED-EX to customers. The letter describes product, problem and actions to be taken by the firm and customers. AGFA will provide a safety check to the customers facility, have a service representative visit , in the near future, their site to inspect the monitor/s and attach a warning label on each monitor checked for preventative action. The customers are ask to distribute the information within their facility to all individuals who need to be aware, to complete the attached URGENT SAFETY NOTICE FEEDBACK FORM a |
| Quantity | 805 units |
| Distribution | Worldwide distribution: USA and countries of Puerto Rico and 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 |