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U.S. Department of Health and Human Services

Class 3 Device Recall Konica Minolta

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  Class 3 Device Recall Konica Minolta see related information
Date Initiated by Firm October 09, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 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 2		 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.
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