FDA Medical Device Recalls (openFDA)
AGFA Healthcare Corp.: 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.
- Recall number
- Z-2178-2014
- Recalling firm
- AGFA Healthcare Corp.
- 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.
- Status
- Terminated
- Initiated
- 2014-07-16
- Posted
- 2014-08-10
- Terminated
- 2014-12-09
- Reason
- Some sheets of the medical screen film are fogged.
- Root cause
- Process design
- Action
- 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.
- Quantity
- 2617
- 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, serial or model codes
- Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWZ
- Firm FEI
- 3001236302
- Firm city
- Greenville
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28