Z-0207-04

SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266

Name: Z-0207-04 SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266
Creator: AGFA Corp.
Published: 2003-11-25
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2003-11-25 / Terminated

FDA source

AGFA Corp. began a recall of SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266 on 2003-11-25. The reason FDA records is "The GS1 circuit board may fail resulting in smoke or fire". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0207-04
Status: Terminated
Initiated: 2003-11-25
Posted: 2003-12-11
Terminated: 2004-10-01
Recalling firm: AGFA Healthcare Corp.
Product: SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.
Product code: LMC Camera, Multi Format, Radiological
Reason for recall: The GS1 circuit board may fail resulting in smoke or fire.
FDA 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 in the enclosed postage paid envelope.
Quantity in commerce: 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
Product codes and lots: Model number LR 5200P, Catalog number: EMQT S000, Types: 8394/600, Serial numbers: 4000 through 5266.

Product code LMC

K964414Class IILr 5200 Laser Film RecorderBayer Corp., Agfa Div. / cleared 1997-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)