Z-2178-2014 Class III Terminated

Recalled by AGFA Healthcare Corp. — Greenville, SC

Recall Details

Product Type
Devices
Report Date
August 20, 2014
Initiation Date
July 16, 2014
Termination Date
December 9, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2617

Product Description

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.

Reason for Recall

Some sheets of the medical screen film are fogged.

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

Code Information

Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063