Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0207-04 · Posted 2003-12-11

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLMC
Date Initiated2003-11-25
Date Terminated2004-10-01
Product QuantityThe units were distributed to hospitals and other health facilities located nationwide

Reason for Recall

The GS1 circuit board may fail resulting in smoke or fire.

Firm 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.

Root Cause

Other

Distribution Pattern

The units were distributed to hospitals and other health facilities located nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964414LR 5200 LASER FILM RECORDERBayer Corp., Agfa Div. · 1997-01-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑