Recall Z-1062-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
AGFA Corp.
Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) Product Usage: DX-D Imaging Package ha the same intended use as the predicative devices: namely to provide diagnostic quality images to aid the physician with diagnosis. The device uses Agfas fla panel detectors with amorphous
| Date | Feb 19, 2012 (initiated Jan 16, 2012) |
| Status | Terminated |
| Reason | The firm received a complaint that when using the DX-D Mobile DR X-Ray unit they noticed the detector cable was hot. |
| Root cause | Device Design |
| Action | AGFA Corp. sent an "URGENT FIELD SAFETY NOTICE" letter dated January 16, 2012 to affected consignees. The letter described the affected product, concerns, issues and actions to be taken. Customers have been requested to place the Varian warning label included in a highly visible and suitable position on the cable of the portable detector. Customers were instructed to complete and return the feedback form by fax to 864-421-1664, as soon as possible. For questions about this matter contact your local AGFA HealthCare Technical Support at 877-777-2432. |
| Quantity | 42 units |
| Distribution | Nationwide Distribution (USA) including the states of: FL, IL, IN, KS, MI, MN, MS, NE,NY, OH, SC and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092669 | DX-D IMAGING PACKAGE Agfa Healthcare N.V., Nov 6, 2009 |