FDAFDA · Food and drugs·Recall number Z-2178-2014
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.
Published August 20, 2014 · Recall initiated: July 16, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some sheets of the medical screen film are fogged.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AGFA Healthcare Corp.
- Distributor
- 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
- Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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