Z-0150-04

Konica Minolta Duplicating Film Emulsions. Konica Medical Film. Emulsion numbers X(=any number), X 742, X842...

Name: Z-0150-04 Konica Minolta Duplicating Film Emulsions. Konica Medical Film. Emulsion numbers X(=any number), X 742, X842...
Creator: Konica Medical Imaging, Inc.
Published: 2003-10-09
License: https://open.fda.gov/license/

Konica Minolta, Inc. / initiated 2003-10-09 / Terminated

FDA source

Konica Medical Imaging, Inc. began a recall of 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... on 2003-10-09. The reason FDA records is "Loss of detail at density of 1.00 to 2.00, on certain bony structures found in original clinical films". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0150-04
Status: Terminated
Initiated: 2003-10-09
Posted: 2004-07-20
Terminated: 2004-07-29
Recalling firm: Konica Minolta, Inc.
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.
Product code: IWZ Film, Radiographic
Reason for recall: Loss of detail at density of 1.00 to 2.00, on certain bony structures found in original clinical films.
FDA root 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.
Product codes and lots: Emulsion''s numbers( X=any number): X742, X842, X152, and X023.

Product code IWZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)