Class 3 Device Recall Konica Minolta

• Date Initiated by Firm: October 09, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on July 29, 2004
• Recall Number: Z-0150-04
• Recall Event ID: 27488
• Product Classification: Film, Radiographic - Product Code IWZ
• Product: Konica Minolta Duplicating Film Emulsions. Konica Medical Film. Emulsion numbers X(=any number), X 742, X842, X152. Film type SR-DUP 8x10, 10x12, 11x14, and 14x17. Film type PPD DUP 10x12 only and Emulsion Number X152. SR-DUP C 14x17 Emulsion X023 only.
• Code Information: Emulsion''s numbers( X=any number): X742, X842, X152, and X023.
• Recalling Firm/ Manufacturer: Konica Medical Imaging, Inc.; 411 Newark Pompton Tpke; Wayne NJ 07470-6657
• For Additional Information Contact: Cliff Hults; 973-633-1500
• Manufacturer Reason for Recall: Loss of detail at density of 1.00 to 2.00, on certain bony structures found in original clinical films.
• FDA Determined Cause: Other
• Action: Recall letter sent out to direct accounts on 10/9/2003. The consignees are to review boxes and cases of emulsion film and contact the firm for a return aurthorization number.
• Quantity in Commerce: 4383
• Distribution: The firm distributed the duplicating firm to 960 imaging locations, clinics, and hospitals nationwide. There are 5 VA medical centers located in VA, RI, WI, NH, and TN.
• 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.