Film, Radiographic
Radiology · 21 CFR 892.1840
Recent MDR events
13 adverse event reports on file
- PORTABLE RADIOGRAPHY UNITFeb 9, 2023MalfunctionAgfa NvMW5114843
- RADIOLOGY XR7 FILM READER/ FILM RADIOGRAPHICMay 25, 2018MalfunctionKonica Minolta, Inc.MW5077469
- RESIUS 190 XPRESOct 13, 2009MalfunctionKonica-minolta Medical Imaging Usa, Inc.1509706
- SYNAPSE SOFTWAREFeb 18, 2008MalfunctionFujifilm Medical SystemsMW5005516
- KODAK ULTRA-SPEEDNov 9, 2005Malfunction*MW1037136
- RADIOLOGY FILMSNov 15, 2004Malfunction*MW1033793
- DF 57C DENTAL X-RAY FILMSep 22, 2004MalfunctionEastman KodakMW1033299
- SILMETJun 10, 2002MalfunctionSilmet UsaMW1025281
- MICROVISION CIMar 31, 2000MalfunctionAgfa Corp.1063474-2000-00001
- CRONEX ORTHO LMar 24, 1998MalfunctionSterling Diagnostic Imaging1043882-1998-00001
Event type breakdown
Recalls
13 recall events for this product code
- AGFA Healthcare Corp.TerminatedDec 16, 2014
Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM
Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
Z-0804-2015 · View FDA record ↗ - AGFA Healthcare Corp.TerminatedAug 10, 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
Some sheets of the medical screen film are fogged.
Z-2178-2014 · View FDA record ↗ - Carestream Health Inc.TerminatedAug 1, 2014
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.
Z-2142-2014 · View FDA record ↗ - Carestream Health Inc.TerminatedAug 1, 2014
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.
Z-2143-2014 · View FDA record ↗ - Carestream Health, Inc.TerminatedJan 28, 2013
KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraor
Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only a
Z-0744-2013 · View FDA record ↗ - Carestream Health, Inc.TerminatedJan 13, 2012
DVB KODAK DRYVIEW --- 35x43 cm --- 125 SHT --- REF 8723132 --- Made in U.S.A. by Carestream Health, Inc., 150 Verona St, Rochester, New York 14608.
Kodak DryView DVB Film is being recalled because it does not meet the specification for maximum density.
Z-0746-2012 · View FDA record ↗ - AGFA Corp.TerminatedNov 25, 2011
Curix Opthos H, size 35x43 cm
The film notch was located in the wrong position.
Z-0285-2012 · View FDA record ↗ - Carestream Health, Inc.TerminatedApr 8, 2010
KODAK T-MAT L/RA Film, Catalog/REF # 181 4631, 35x43 cm 5-100 Sheet Boxes Folhas/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester
Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it was performing like T-MAT G/RA.
Z-1314-2010 · View FDA record ↗ - Carestream Health, Inc.TerminatedApr 8, 2010
KODAK T-MAT G/RA Film, Catalog/REF # 151 0023, 24x30 cm, 5-100 Sheet Boxes FOLHAS/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester,
Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it was performing like T-MAT G/RA.
Z-1315-2010 · View FDA record ↗ - AGFA Corp.TerminatedApr 22, 2006
Mamoray HDR-C PLUS Mammography film
The film was incorrectly notched.
Z-0788-06 · View FDA record ↗
Registered firms
52 firms currently registered for this product code
Shanghai Alwings Medical Instrument Co.,ltd.
Shanghai, CN
Ashland
Columbus, OH, US
Wolf X-ray Corp
Battleboro, NC, US
Jmu Dental, Inc
Fullerton, CA, US
Ashland Specialty Ingredients, G.p.
Fiskeville, RI, US
White Mountain Imaging
Concord, NH, US
Air Techniques, Inc.
Melville, NY, US
Carestream Dental Llc
Atlanta, GA, US
Integra Lifesciences Corporation
Princeton, NJ, US
Samtrade Supplies Inc.
TORONTO Ontario, CA
Zaw Ggmbh
Balingen Baden-Wurttemberg, DE
Hpc Medx
HANOVER, PA, US
Patterson Dental Supply, Inc.
ST. PAUL, MN, US
Sun Nuclear Corporation
NORFOLK, VA, US
Codonics, Inc.
Middleburg Heights, OH, US
Indusbello Industria De Instrumentos Odo
Londrina Parana, BR
Carestream Health, Inc.
Rochester, NY, US
Biotronix Healthcare Industries Inc.
Orlando, FL, US
Fujifilm Corporation
ASHIGARAKAMI-GUN Kanagawa, JP
Oketz Logistics Llc
Coral Gables, FL, US
Aktina Medical Corp.
Congers, NY, US
Mainline Medical Dental Supply
North York Ontario, CA
Medlink Imaging, Llc.
Pine Brook, NJ, US
Zogear Medical Co., Ltd.
Yizheng Jiangsu, CN
Ashland Specialty Ingredients, G.p.
Bridgewater, NJ, US
510(k) clearances
34 clearances for this product code
- Eastman Kodak CompanyApr 4, 1997
K970154 · KODAK EKTASIAN HG FILM (EHG-15)
- VoxelSep 29, 1995
K954200 · VOXGRAM
- 3M Health Care, Ltd.Jul 21, 1993
K931604 · 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE
- 3M Health Care, Ltd.Jul 20, 1993
K931605 · 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE
- Burkhart Roentgen Intl., Inc.Jun 30, 1992
K920539 · ORWO X-RAY FILM
- Eastman Kodak CompanyJan 30, 1989
K884827 · KODAK DENTAL BARRIER PAC
- Eastman Kodak CompanyAug 12, 1986
K862944 · KODAK CFT FILM SO-141
- Parexel Intl. Corp.Jul 1, 1986
K862415 · TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM