Recall Z-1738-2017 ยท KPR System, X-Ray, Stationary
AGFA Healthcare Corp.
DX-D600 - DXD Imaging Package
| Date | Apr 5, 2017 (initiated May 2, 2016) |
| Status | Terminated |
| Reason | One of the dent markers from the DX-D600 dropped down from the overhead rail. |
| Root cause | Labeling design |
| Action | On May 2, 2016, an "URGENT FIELD SAFETY NOTICE" letter was either emailed or sent via FedEx to the US and Canadian consignees. The notice included an acknowledgment to be sent back. The letter described background information and actions to be taken. |
| Quantity | 81 units |
| Distribution | AL, CA, DC, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, NV, NJ, NM, NY, OH, OK, OR, SC, TN, TX, VA, and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112670 | DX-D 600 Agfa Healthcare N.V., Oct 27, 2011 |