Konica Minolta Duplicating Film Emulsions. Konica Medical Film. Emulsion numbers X(=any number), X 742, X842, X152. Film
FDA device recall Z-0150-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Konica Medical Imaging, Inc.
- Reason for recall
- Loss of detail at density of 1.00 to 2.00, on certain bony structures found in original clinical films.
- Action taken
- 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
- Status
- Terminated
- Product code
- IWZ
- Quantity affected
- 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.
- Date initiated
- 2003-10-09
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-29
- Location
- Wayne, NJ
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