FDA Medical Device Recalls (openFDA)
Konica Medical Imaging, Inc.: 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.
- Recall number
- Z-0150-04
- Recalling firm
- Konica Medical Imaging, 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.
- Status
- Terminated
- Initiated
- 2003-10-09
- Posted
- 2004-07-20
- Terminated
- 2004-07-29
- Reason
- Loss of detail at density of 1.00 to 2.00, on certain bony structures found in original clinical films.
- 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
- 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.
- Lot, serial or model codes
- Emulsion''s numbers( X=any number): X742, X842, X152, and X023.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWZ
- Firm FEI
- 2241281
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28