Events

Recall of Double Foot Switch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ziehm Imaging Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60661
  • Event Risk Class
    Class 2
  • Event Number
    Z-1430-2012
  • Event Initiated Date
    2011-04-29
  • Event Date Posted
    2012-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106154
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • 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.
  • 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.

Device

Double Foot Switch
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Ziehm Imaging Inc

Manufacturer

Ziehm Imaging Inc
  • Manufacturer Address
    Ziehm Imaging Inc, 6280 Hazeltine National Dr, Suite 100, Orlando FL 32822-5114
  • Manufacturer Parent Company (2017)
    Aton 2 Gmbh
  • Source
    USFDA