Recall Z-2178-2014— AGFA Healthcare Corp.
Class III · Terminated
Class III FDA medical device recall by AGFA Healthcare Corp., initiated 2014-07-16, terminated 2014-12-09. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Some sheets of the medical screen film are fogged..
- Recalling firm
- AGFA Healthcare Corp.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-07-16
- Terminated
- 2014-12-09
- Firm location
- Greenville, SC, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.