Generator, High-voltage, X-ray, Diagnostic
Radiology · 21 CFR 892.1700
Recent MDR events
160 adverse event reports on file
- Unnamed deviceMay 4, 2026No answer providedCOR26000112-000
- KONICA MINOLTAMar 27, 2023MalfunctionSedecal Sa9617251-2023-00002
- KONICA MINOLTAMar 21, 2023MalfunctionSedecal Sa9617251-2023-00001
- HF UNIT "ESG-400"Feb 1, 2023MalfunctionOlympus Winter & Ibe Gmbh Berlin Facility9610773-2023-00405
- Unnamed deviceSep 26, 2022No answer providedCOR22000174-000
- Unnamed deviceMar 10, 2020No answer providedCOR20000080-000
- Unnamed deviceMar 10, 2020No answer providedCOR20000081-000
- Unnamed deviceFeb 19, 2020No answer providedCOR20000067-000
- GENERATOR, HIGH-VOLTAGE, X-RAY, DIAGNOSTICJun 18, 2019MalfunctionCommunications & Power Industries Canada, Inc8707260
- ANTHEM GENERATORApr 15, 2019MalfunctionDel Medical Inc.1418964-2019-00015
Event type breakdown
Recalls
4 recall events for this product code
- Philips Healthcare Inc.TerminatedMar 4, 2011
BuckyDiagnost general purpose x-ray system with Optimus Generator.
Affected systems were determined not to prevent run-on of a selected technique factor if the technique selector and the exposure control were activated simultaneously.
Z-0905-2011 · View FDA record ↗ - Mallinckrodt IncTerminatedJun 25, 2010
Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237.
Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lead to the generator becoming inoperative.
Z-1904-2010 · View FDA record ↗ - GE HealthcareTerminatedOct 27, 2008
Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after March 8, 1985 for Advantx Legacy, RFX and SFX syste
GE Healthcare has recently become aware of a potential risk of monitor dropping associated with the monitor suspension of the Advantx system that may impact patient safety. It has been reported that suspensions manufactured after March 8, 1995 did not have the required thread locking agent applied to the setscrew, allowing the setscrew to back out over time, which can lead to the monitor dropping
Z-0200-2009 · View FDA record ↗ - Shimadzu Medical SystemsTerminatedUnknown
Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube
Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.
Z-0918-2017 · View FDA record ↗
Registered firms
45 firms currently registered for this product code
Ge Be Private Limited
WHITEFIELD, BANGALORE Karnataka, IN
Spellman High Voltage Electronics Corp.
HAUPPAUGE, NY, US
Drgem Corporation (gimcheon Factory)
Gimcheon-si Gyeongbuk, KR
Suzhou Powersite Electric Co., Ltd.
Suzhou Jiangsu, CN
Medicatech Usa
Anaheim, CA, US
Sg Healthcare Co Ltd
Moga-myeon, Icheon-si Gyeonggi, KR
Varex Imaging Philippines Inc.
Batino, Calamba City Laguna, PH
Philips Medical Systems Dmc Gmbh
HAMBURG, DE
Iray Imaging Technology (haining) Limited
Haining Zhejiang, CN
Ge Medical Systems Ultrasound & Primary Care Diagnostics Llc
MADISON, WI, US
Drtech Corporation
Seongnam-si Gyeonggi, KR
Gilardoni S.p.a.
MANDELLO DEL LARIO Lecco, IT
Philips Medical Systems Nederland B.v.
BEST Noord-Brabant, NL
Carestream Healthcare International Company, Ltd
Shanghai, CN
Varex Imaging Corporation
Franklin Park, IL, US
Carestream Health, Inc., Global R&d Center
SHANGHAI, CN
Ge Medical Systems Scs
BUC, FR
Shinyoung For M Co., Ltd.
Namyangju-si Gyeonggi, KR
Emd Technologies Incorporated
SAINT-EUSTACHE Quebec, CA
Hefei Mt Medical Co.,ltd.
Hefei Anhui, CN
Althea Us, Inc.
Goodlettsville, TN, US
Umi Intl.
Norwood, NJ, US
Spellman High Voltage Electronics(suzhou Industrial Park)co.,ltd
Suzhou Jiangsu, CN
Del Medical, Inc.
Bloomingdale, IL, US
510(k) clearances
163 clearances for this product code
- GE Medical SystemsNov 24, 1995
K954666 · MPH50, MPH65, AND MPH80
- Varian Canada, Inc.Sep 26, 1995
K953582 · HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
- Nucletron-Oldelft Corp.Sep 8, 1995
K953831 · N 800 HF
- Shimadzu Corp.Jul 12, 1995
K952822 · SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
- Control-X, Inc.Jul 6, 1995
K952265 · MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR
- Siemens Medical Solutions USA, Inc.Apr 3, 1995
K950883 · POLYDOROS SX 65 AND 80
- Electromed Intl., Ltd.Mar 31, 1995
K950694 · COMPACT-X
- Fischer Imaging Corp.Mar 23, 1995
K950291 · DIGITAL 625HF