Camera, X-ray, Fluorographic, Cine Or Spot
Radiology · 21 CFR 892.1620
Recent MDR events
9 adverse event reports on file
- ADAC NM SYSTEMAug 12, 2023InjuryPhilipsMW5141873
- ARRIFLEXOct 17, 2003OtherArri, Inc506914
- KODAK X-MATIC ID CAMERAFeb 15, 2000MalfunctionEastman Kodak Co.1315356-2000-00001
- SIEMENSDec 4, 1998MalfunctionSiemens Medical SystemsMW1015111
- ARRITECHNO CINE CAMERAMar 30, 1998MalfunctionPhilips Medical Systems1217116-1998-00009
- ARRITECHNO CINE CAMERAMar 16, 1998MalfunctionPhilips Medical Systems1217116-1998-00008
- INTEGRIS CATH LAB SYSTEMMay 14, 1996MalfunctionSiemens Medical SystemsMW1009098
- CINEPROJECTORMay 20, 1995OtherTagarno24823
- CINE CAMERA - ARRITECHNO CAMERADec 30, 1992MalfunctionSiemens Medical Systems, Inc.3593
Event type breakdown
Recalls
2 recall events for this product code
- Philips Medical Systems (Cleveland) IncTerminatedJan 17, 2014
ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies in the fork weldment.
Z-0785-2014 · View FDA record ↗ - Philips Medical Systems North America Co. PhillipsTerminatedAug 25, 2008
General X-Ray System types with Digital Spot Imaging (DSI) software
X-ray images may be stored in the wrong patient file or corrupted, images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted).
Z-2160-2008 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
12 clearances for this product code
- Perkins Electronics Co.Mar 11, 2003
K024085 · CCD CAMERA, MODEL PKP-06000-000
- FairmontmedicalOct 9, 1997
K972130 · DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR
- Philips Medical Systems (Cleveland), Inc.Jan 30, 1995
K945580 · DSP OPTION
- Philips Medical Systems, Inc.Jul 17, 1992
K920793 · PHILIPS DSI SYSTEM RELEASE 3.2
- Perkins Mfg. Co.Jan 4, 1990
K896615 · CINE CAMERA CONTROL MODEL PK2037
- Adac LaboratoriesMay 18, 1988
K881688 · DTV-4114 FLUOROSCOPIC TELEVISION CAMERA
- Canon USA, Inc.Oct 16, 1985
K853983 · CANON X-RAY 35MM CINE CAMERA CSI-35
- Diversified P.A.Dec 8, 1981
K812613 · VIDICAM 200