Camera, Multi Format, Radiological
Radiology · 21 CFR 892.2040
Recent MDR events
6 adverse event reports on file
- DRYPIX 7000Nov 7, 2018DeathFujifilm Corporation3001722928-2018-00059
- DRYPIX 7000Nov 7, 2018DeathFujifilm Corporation2443168-2018-00002
- 8900 DRYVIEW LASERSep 29, 2014MalfunctionCarestream Health, Inc.2134259-2014-00016
- *Jun 26, 2013MalfunctionSony Electronics Inc., Medical Systems Division3203946
- UP-51MDNov 9, 2006MalfunctionSony Emcs Corp. Kohda Tech. Ctr2246606-2006-00001
- KODAK EKTASCAN LASER PRINTER 2180Nov 9, 1999InjuryEastman Kodak Co. Health Imaging Division1315356-1999-00001
Event type breakdown
Recalls
3 recall events for this product code
- Philips Medical Systems (Cleveland) IncTerminatedMay 13, 2015
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60)
The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.
Z-1607-2015 · View FDA record ↗ - AGFA Corp.TerminatedSep 18, 2008
Drystar AXYS, Hardcopy Printer
The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".
Z-2136-2008 · View FDA record ↗ - AGFA Corp.TerminatedDec 11, 2003
SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.
The GS1 circuit board may fail resulting in smoke or fire.
Z-0207-04 · View FDA record ↗
Registered firms
27 firms currently registered for this product code
Agfa-gevaert Healthcare Gmbh
PEISSENBERG Bavaria, DE
Agfa N.v.
Mortsel Antwerpen, BE
Konica Minolta, Inc.
HACHIOJI-SHI Tokyo, JP
Sony Global Manufacturing & Operations Corporation Kohda Site
Nukata-gun Aichi, JP
Medisono, Llc
Doral, FL, US
Fujifilm Corporation
ASHIGARAKAMI-GUN Kanagawa, JP
Bay Shore Medical Equipment, Llc
Manorville, NY, US
Konica Minolta, Inc.
HINO-SHI Tokyo, JP
Fujifilm Imaging System (suzhou) Co., Ltd.
Suzhou Jiangsu, CN
Sony Corporation
Yokohama-shi Kanagawa, JP
Siemens Healthineers Ag
FORCHHEIM Bavaria, DE
Toyo Medical Co.
Doral, FL, US
Qisda Electronics (suzhou) Co., Ltd.
Suzhou Jiangsu, CN
Konica Minolta Technoproducts Co., Ltd.
SAYAMA-SHI Saitama, JP
Codonics, Inc.
Middleburg Heights, OH, US
Icrco Inc.
Goleta, CA, US
Ziphycare, Inc.
New York, NY, US
510(k) clearances
121 clearances for this product code
- Sony Electronics, Inc.Jun 26, 2014
K141454 · SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
- Sony Electronics, Inc.Jun 26, 2014
K141346 · SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD
- Carestream Health, Inc.Oct 6, 2011
K111566 · DRYVIEW CHROMA IMAGING SYSTEM
- Virtual Imaging, Inc.Oct 16, 2009
K092280 · CYPHER DICOM PRINT SOLUTION
- Carestream Health, Inc.May 22, 2009
K090469 · CARESTREAM DRYVIEW 5850 LASER IMAGER
- Sony Electronics, Inc.Jan 9, 2009
K083522 · SONY UP-DF750 DIGITAL FILM IMAGER
- Konica Minolta Medical & Graphic, Inc.Jul 1, 2008
K081637 · LASER IMAGER DRYPRO MODEL 873
- Agfa Healthcare CorporationOct 25, 2007
K072680 · DRYSTAR AXYS, MODEL EYZ4E