SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.
This recall has been terminated (originally issued December 11, 2003).
- Company
- Agfa Corp.
- Recall Initiated
- November 25, 2003
- Posted
- December 11, 2003
- Terminated
- October 1, 2004
- Recall Number
- Z-0207-04
- Quantity
- The units were distributed to hospitals and other health facilities located nationwide
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
The GS1 circuit board may fail resulting in smoke or fire.
Distribution
The units were distributed to hospitals and other health facilities located nationwide
Lot / Code Info
Model number LR 5200P, Catalog number: EMQT S000, Types: 8394/600, Serial numbers: 4000 through 5266.
Root Cause
Other
Action Taken
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 in the enclosed postage paid envelope.