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U.S. Department of Health and Human Services

Class 2 Device Recall Double Foot Switch

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 Class 2 Recall
Double Foot Switch
see related information
Date Posted April 16, 2012
Recall Status1 Terminated on April 18, 2012
Recall Number Z-1430-2012
Recall Event ID 60661
Premarket Notification
510(K) Numbers
K061203  K073346  K083545  K092438 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product 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.
Code Information C-Arm Device Model # Ziehm Vision2 Family; serial numbers: 90209, 90222, 90225, 90227, 90228, 90230, 90245, 902046, 90250, 90251, and 90269. Ziehm Vision2 FD, Ziehm Vision2 FD Vario 3D serial numbers: 90197, 90241, 90242, 90243, and 90249. Ziehm Vision R; serial numbers: 10287, 10288, 10289, 10290, 10295, 10297, and 10317. Ziehm Vision RFD; serial numbers: 20048 and 20049. Ziehm Solo; serial numbers: 50105, 50138, 50144, 50155, 50156, 50164, 50163, 50165, 50166, 50172, 50173, 50182, 50179, 50183, 50191, 50195, 50197, 50199, 50402, 50404, 50405, 50406, 50421, and 50422.
Recalling Firm/
Manufacturer
Ziehm Imaging Inc
6280 Hazeltine National Dr
Suite 100
Orlando, Florida 32822-5114
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Richard Westrich
866-949-4346
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action 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.
Quantity in Commerce 49 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = ZIEHM IMAGING, INC.
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