Shield, Protective, Personnel
Radiology · 21 CFR 892.6500
Recent MDR events
71 adverse event reports on file
- RADIATION SHIELD SYSTEMAug 12, 2023InjuryKenexMW5134319
- HARMONY RSHIELD RADIATION PROTECTION DEVICEFeb 16, 2022MalfunctionSteris Corporation - Montgomery1043572-2022-00014
- HARMONY RSHIELD RADIATION PROTECTION DEVICEDec 28, 2020MalfunctionSteris Corporation - Montgomery1043572-2020-00067
- NIKESep 16, 2020MalfunctionBloxr Solutions Llc10540323
- DRAPE ARMOURFeb 3, 2017MalfunctionMicrotek Dominicana, S.a.8043817-2017-00003
- N/AApr 26, 2016MalfunctionEl Dorado Metals5607590
- HANELAug 17, 2015MalfunctionMavig Gmbh9680506-2015-00001
- RF DESIGNMay 2, 2012MalfunctionRf Design, Inc.2561627
- CLEAR-PB MOBILE BARRIERSApr 9, 2012MalfunctionFluke Biomedical2921581-2012-00001
- MAVIGSep 21, 2011MalfunctionMavigMW5022356
Event type breakdown
Recalls
2 recall events for this product code
- GE HealthcareTerminatedApr 13, 2015
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.
Z-1441-2015 · View FDA record ↗ - GE Healthcare, LLCTerminatedJun 3, 2014
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is not related to the design of the Kenex product. The affected products are limited to installations completed or contracted by GE Healthcare. There has been a reported incident of a radiation shield falling from the ceil
Z-1706-2014 · View FDA record ↗
Registered firms
197 firms currently registered for this product code
Bwxt Medical Ltd.
OTTAWA Ontario, CA
Mirion Technologies (capintec), Inc
Florham Park, NJ, US
Hebumedical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Tangshan Zhengtong Exhibition Co., Ltd.
Tangshan Hebei, CN
Teleflex Medical Llc
Morrisville, NC, US
Anji Spenq Industrial Co., Ltd.
Huzhou Zhejiang, CN
Foresight Optical Ltd.
TAINAN, TW
Anhui Dajiang Medical Products Co.,ltd.
chuzhou Anhui, CN
Taijia Medical Electronics (shenzhen) Co.,ltd
Shenzhen Guangdong, CN
Diamond Mark International Co., Ltd.
TAIPEI, TW
Beijing Kelida Medical Equipment Developing Co., Ltd
Beijing City, CN
Zogear Medical Co., Ltd.
Yizheng Jiangsu, CN
Debo Medical Technology (shijiazhuang) Co., Ltd.
Shijiazhuang Hebei, CN
Shanghai Caremate Medical Device Co. Ltd
Shanghai, CN
Honghu Danielle Sanitary Material Co., Ltd.
Honghu City Hubei, CN
Discus Dental, Llc
Ontario, CA, US
Ultralight Optics Inc.
Westminster, CA, US
Huzhou Junda Industry Co., Ltd.
Anji Zhejiang, CN
Prestige Ameritech
North Richland Hills, TX, US
Qinhuangdao Taizhi Medical Technology Co., Ltd
Qinhuangdao Hebei, CN
Barrier Technologies, Llc
Davie, FL, US
Sirtex Singapore Manufacturing Pte Ltd
Singapore Central Singapore, SG
Tf New Material Sci And Tec Co.,ltd
Huainan Anhui, CN
Molded Products Inc.
HARLAN, IA, US
Lemer Pax America
Montreal Quebec, CA
510(k) clearances
25 clearances for this product code
- Bloxr CorporationJun 24, 2011
K110900 · DISPOSABLE THYROID COLLAR
- Medtec, Inc.Oct 1, 1996
K962622 · INTRA-ORAL THERMOPLASTIC SHIELD
- Medtec, Inc.Dec 21, 1995
K954456 · THERMOPLASTIC SHIELD
- Mallinckrodt MedicalDec 6, 1995
K954146 · UTK-DTE AUTILARY SHIELD
- Aukland Medical Plastics, Inc.Sep 26, 1995
K953610 · AUKULYTE
- Kenex , Ltd.Apr 10, 1995
K951004 · 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)
- Kenex , Ltd.Apr 3, 1995
K951003 · KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)
- Standard Imaging, Inc.Mar 16, 1994
K940539 · STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM