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.
Recall
- Recall Number
- Z-1430-2012
- Event Number
- 60661
- Firm
- Ziehm Imaging Inc
- FEI Number
- 2027299
- Product Code
- JAA
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- April 29, 2011
- Posted
- April 16, 2012
- Terminated
- April 18, 2012
- Address
- 6280 Hazeltine National Dr, Suite 100, Orlando, FL, 32822-5114
Description
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.
On 04/29/2011, Ziehm Imaging, Inc., Orlando, FL recalled the double foot switch, type KF 2 1S/1S-MED-AP, a component used with Ziehm Imaging GmbH Mobile C-arm due to the potential of unintentional continued activation of fluoroscopic X-ray as the foot switch may not become inactive when the pedal is released.
Ziehm Imaging, Inc., Orlando, FL sent an Urgent Recall Notice letter dated April 11, 2011, that included a return receipt request, envelope, and a reply questionnaire. to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. They also called consignees. After contact, Ziehm Imaging, Inc. shipped a replacement foot switch with instructions for the customer/end user on how to install the replacement foot switch. If no signed confirmation was received, Ziehm Imaging, Inc. visited the consignee and replaced the foot switch. Customers were asked to fax the completed response form to 866-839-7893.
Nationwide Distribution including Florida, South Carolina, Georgia, Alabama, Virginia, Ohio, Massachusetts, New York, Pennsylvania, Kentucky, Connecticut, Rhode Island, Indiana, Illinois, Nebraska, Minnesota, Arizona, California, Oregon, and Washington.
49 units