Device product
Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.
Z-2178-2014
Product summary
- Event
- Event 68844
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2617
- Official record key
device-enforcement:Z-2178-2014
Official wording
Reason: Some sheets of the medical screen film are fogged.
Code information: Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063
Distribution pattern: Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada
Derived failure modes
-
Unknown
Some sheets of the medical screen film are fogged.