Recall Z-1430-2012 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Ziehm Imaging Inc
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 as
| Date | Apr 16, 2012 (initiated Apr 29, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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. Custome |
| Quantity | 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. |
| FDA record | Open on fda.gov |