AGFA Corp. SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.
Brand
AGFA Corp.
Lot Codes / Batch Numbers
Model number LR 5200P, Catalog number: EMQT S000, Types: 8394/600, Serial numbers: 4000 through 5266.
Products Sold
Model number LR 5200P, Catalog number: EMQT S000, Types: 8394/600, Serial numbers: 4000 through 5266.
AGFA Corp. is recalling SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266. due to The GS1 circuit board may fail resulting in smoke or fire.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The GS1 circuit board may fail resulting in smoke or fire.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026