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Terminated

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.

FDA Recall Z-0150-04 · Posted 2004-07-20

Recalling FirmKonica Medical Imaging, Inc.
Recall StatusTerminated
Product CodeIWZ
Date Initiated2003-10-09
Date Terminated2004-07-29
Product Quantity4383

Reason for Recall

Loss of detail at density of 1.00 to 2.00, on certain bony structures found in original clinical films.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

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

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