FDA Medical Device Recalls (openFDA)
AGFA Corp.: SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.
- Recall number
- Z-0207-04
- Recalling firm
- AGFA Corp.
- Product
- SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.
- Status
- Terminated
- Initiated
- 2003-11-25
- Posted
- 2003-12-11
- Terminated
- 2004-10-01
- 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 in the enclosed postage paid envelope.
- 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
- Lot, serial or model codes
- Model number LR 5200P, Catalog number: EMQT S000, Types: 8394/600, Serial numbers: 4000 through 5266.
- 510(k) numbers
- K964414
- PMA numbers
- not on file
- Product code
- LMC
- Firm FEI
- 3001236302
- Firm city
- Greenville
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28