29 results
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31ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Imaging solo FD Mobile Fluoroscopic C-arm
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·February 23, 2017
Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·April 15, 2016
Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·April 15, 2016
Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code JAA·April 15, 2016
Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·April 15, 2016
Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·April 15, 2016
Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code JAA·April 15, 2016
Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·November 21, 2013
Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·November 21, 2013
Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·November 21, 2013
Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·November 21, 2013
Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·November 21, 2013
Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·November 21, 2013
Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
FDA Recall
Terminated
·Ziehm Imaging Inc·Product code OWB·November 21, 2013
Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Enforcement
Class II
·Terminated·Ziehm Imaging Inc·August 31, 2016
Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Enforcement
Class II
·Terminated·Ziehm Imaging Inc·August 31, 2016
Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Enforcement
Class II
·Terminated·Ziehm Imaging Inc·August 31, 2016
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
FDA Enforcement
Class II
·Terminated·Ziehm Imaging Inc·May 24, 2017
Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Enforcement
Class II
·Terminated·Ziehm Imaging Inc·August 31, 2016