Device Recall Radiomat

  • Model / Serial
    Product Code: EK8JR, Manufacturing Batch or Lot: 79360104 and Product Code: EK8DG, Manufacturing Batch or Lot: 79360104
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AL, AZ, CA, CO, FL, GA, IN, MA, MI, NC, NJ, NY, OR, SC, TN, TX, WA, VA and Canada
  • Product Description
    Radiomat¿ SG, 11x14, Medical Screen Film, X-ray Film, 100 Sheet Box and 14x17, 100 Sheet Box
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • 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
  • 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.
  • Manufacturer