Recall Z-0207-04 ยท LMC Camera, Multi Format, Radiological
AGFA Corp.
SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.
| Date | Dec 11, 2003 (initiated Nov 25, 2003) |
| Status | Terminated |
| Reason | The GS1 circuit board may fail resulting in smoke or fire. |
| Root cause | Other |
| Action | Consignees were notified by letter on 11/25/2003. They were informed of the problem and were advised, if they have the affected type and serial number, to contact the Agfa service representative to arrange for repair. The firm intends to install a modified circuit board on each machine remaining in operation at customer locations. Consignees were instructed to discontinue use of the device immediately and to disconnect the unit from the power supply if any odor of smoke or fire is detected. They were urged to complete the Customer Acknowledgement form included with the letter and return it i |
| Quantity | The units were distributed to hospitals and other health facilities located nationwide |
| Distribution | The units were distributed to hospitals and other health facilities located nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964414 | LR 5200 LASER FILM RECORDER Bayer Corp., Agfa Div., Jan 27, 1997 |