Recall Z-1599-2016 ยท IXW Processor, Radiographic-Film, Automatic
Fujifilm Medical Systems U.S.A., Inc.
Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
| Date | Apr 1, 2016 |
| Status | Terminated |
| Reason | Reports of failure of the device's power supply. |
| Root cause | Device Design |
| Action | Fujifilm sent an Medical Device Correction letter dated March 22, 2016, via FedEx to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions for turning the unit off when not in use as an interim action. FMSU will conduct a field replacement of the power supply in all installed units. For further questions, please call (888) 385-4633. |
| Quantity | 2,062 devices |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944046 | FUJI COMPUTED RADIOGRAPHY SYSTEMS Fujifilm Medical System U.S.A., Inc., May 11, 1995 |