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U.S. Department of Health and Human Services

Class 2 Device Recall SCOPIX LR 5200P Laser Imagers

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  Class 2 Device Recall SCOPIX LR 5200P Laser Imagers see related information
Date Initiated by Firm November 25, 2003
Date Posted December 11, 2003
Recall Status1 Terminated 3 on October 01, 2004
Recall Number Z-0207-04
Recall Event ID 27844
510(K)Number k964414  
Product Classification Camera, Multi Format, Radiological - Product Code LMC
Product SCOPIX ¿ LR 5200P¿ Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.
Code Information Model number LR 5200P, Catalog number: EMQT S000, Types: 8394/600, Serial numbers: 4000 through 5266.
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Jeffery A. Jedlicka
864-421-1815
Manufacturer Reason
for Recall		 The GS1 circuit board may fail resulting in smoke or fire.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LMC and Original Applicant = BAYER CORP., AGFA DIV.
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