48 results
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40ms
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Sources: EU EUDAMED, US FDA
VISION R-FD FLAT PANEL DIGITAL MOBILE C-ARM
FDA Adverse Event
Malfunction
·ZIEHM IMAGING INC.·Product code JAA·September 27, 2016
Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code OWB·August 8, 2024
Ziehm Solo. Digital Mobile C-arm
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code OWB·August 8, 2024
Ziehm Solo FD. Interventional fluoroscopic x-ray system
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code OWB·August 8, 2024
Ziehm Vision R. Iterventional fluoroscopic x-ray system
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code OWB·August 8, 2024
Ziehm Vision FD. Interventional fluoroscopic x-ray system
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code OWB·August 8, 2024
Ziehm Vision system, x-ray, tomography, computed.
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code JAK·August 8, 2024
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
FDA Recall
Open, Classified
·Orthoscan, Inc.·Product code OWB·August 8, 2024
ZIEHM IMAGING
FDA Adverse Event
Malfunction
·ZIEHM IMAGING, INC.·Product code JAA·April 30, 2007
EXPOSCOP 700
FDA Adverse Event
Malfunction
·ZIEHM IMAGING, INC.·Product code JAA·April 30, 2007
ZIEHM VISTA
FDA Adverse Event
Other
·ZIEHM IMAGING, INC.·Product code JAA·October 25, 2005
ZIEHM
FDA Adverse Event
Malfunction
·ZIEHM IMAGING INC.·Product code JAA·August 21, 2012
Ziehm Vision system, x-ray, tomography, computed.
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
Ziehm Vision R. Iterventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
Ziehm Solo FD. Interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
Ziehm Vision FD. Interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
Ziehm Solo. Digital Mobile C-arm
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
Double foot switch, type KF 2 1S/1 S-MED-AP, manufactured by the company Seute Schaltgerate. GmbH & Co. KG for Ziehm Imaging GmbH Germany, and used with Ziehm Imaging GmbH Mobile C-arm as a component thereof. Two versions were made: 2 pedal version KF 2 1S/1 S-MED-AP foot switch and 4 pedal foot switch version KF 2 1S/1 S-MED-AP This type of foot switch includes a pair of the dual foot switches assembled on a single metal bracket. The following labels may appear on the foot switch: Labeled in part: "Fluoro- Store***ZIN Part no. # 58371***ZIR Part no. # 10-2985*** Left Pedal: Initiate Radiation***Right Pedal: Store Image***" Labeled in part: "Fluoro - Cine***ZIN Part no. # 58415***ZIR Part no. # 10-2987*** Left Pedal: Initiate Radiation***Right Pedal: Switch into Cine mode***" Labeled in part: "Fluoro - Mag***ZIN Part no. # 58413***ZIR Part no. # 10-2989*** Left Pedal: Initiate Radiation***Right Pedal: Switch through magnification***" Labeled in part: "Fluoro -Snap***ZIN Part no. # 58417***ZIR Part no. # 10-2991*** Left Pedal: Initiate Radiation ***Right Pedal: Initiate Snapshot***" Labeled in part: "DSA - CINE***ZIN Part no. # 58419***ZIR Part no. # 10-2993*** Left Pedal: Switch into DSA mode ***Right Pedal: Switch into Cine mode***" Labeled in part: "Cine - Store***ZIN Part no. # 58421***ZIR Part no. # 10-2995*** Left Pedal: Switch into Cine mode***Right Pedal: Store Image***" Labeled in part: "Cine - LONG:Endo ON/OFF & SHORT:Freeze*** ZIN Part no. # 58423***ZIR Part no. # 10-2997*** Left Pedal: Switch into Cine mode***Right Pedal: Long: Switch Endo On/Off Short: Freeze the endoscopic image on live screen***" Labeled in part: "Cine- Endo ON /OFF***ZIN Part no. # 58425***ZIR Part no. # 10-2999*** Left Pedal: Switch into Cine mode***Right Pedal: Switch Endo On / Off***" Labeled in part: "Fluoro - Swap***ZIN Part no. # 58427***ZIR Part no. # 10-3031*** Left Pedal: Initiate Radiation***Right Pedal: Swaps the image between the live and reference screens***" Labeled in part: "DSA / MSA/RSA - OFF***ZIN Part no. #58429***ZIR Part no. #10-3033***Left Pedal: Switch DSA/MSA/RSA On***Right Pedal: Switch DSA/MSA/RSA Off***" The KF 2 1S/1S-MED- AP foot switch is a component of the Mobile C-arm and is used by the physician to activate Fluoroscopic X-Ray for imaging by pressing the foot switch.
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code JAA·April 29, 2011
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024