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.
This recall has been terminated (originally issued August 10, 2014).
- Company
- Agfa Healthcare Corp.
- Recall Initiated
- July 16, 2014
- Posted
- August 10, 2014
- Terminated
- December 9, 2014
- Recall Number
- Z-2178-2014
- Quantity
- 2617
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
Some sheets of the medical screen film are fogged.
Distribution
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
Lot / Code Info
Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063
Root Cause
Process design
Action Taken
On July 16, 2014, an "URGENT FIELD SAFETY NOTICE" letter was sent to the US and Canadian dealers (consignees). The letter described the safety alert and the request to quarantine affected product. Acknowledgment, via FAX-Back or email, that the information was received and understood was requested from the dealers. A customer Urgent Field Safety Notice was also provided to those dealers who had shipped affected product to end users so that it could be sent to their customers.