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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/
Konica Medical Imaging, Inc.
411 Newark Pompton Tpke
Wayne NJ 07470-6657
For Additional Information Contact Cliff Hults
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
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.