Recall Z-0150-04 ยท IWZ Film, Radiographic
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.
| Date | Jul 20, 2004 (initiated Oct 9, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.