FDA Device

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 p

Hazard

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.

What You Should Do

Remedy

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.

Products

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
Brand
Ziehm Imaging Inc
UPC
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.

Units Affected

49 units