Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
This recall has been terminated (originally issued December 24, 2013).
- Company
- Ziehm Imaging Inc
- Recall Initiated
- November 21, 2013
- Posted
- December 24, 2013
- Terminated
- June 23, 2014
- Recall Number
- Z-0563-2014
- Quantity
- 58 devices
- Firm Location
- Orlando, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.
Distribution
USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
Lot / Code Info
50104 50694 50704 50714 50812 50875 50105 50695 50705 50785 50813 50901 50106 50696 50706 50786 50815 50902 50107 50697 50707 50802 50817 50925 50108 50698 50708 50803 50818 50926 50109 50699 50709 50804 50819 50927 50653 50700 50710 50805 50820 50937 50663 50701 50711 50808 50872 50939 50671 50702 50712 50810 50873 50693 50703 50713 50811 50874
Root Cause
Device Design
Action Taken
Ziehm Imaging sent an "URGENT RECALL NOTICE" letter dated November 22, 2013, to all affected customers. The letter identified the products the problem and the action needed to be taken by the customers. Customers were advised and instructed to: Your Model and Serial number can be found on the product label attached to the side of the mobile C-arm Stand. Our records indicate that your facility has one or more of the products listed above that are being used in your facility. Recall of the product was initiated because according to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device for vertical travel of the c-arm imaging assembly. To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device identification and label. The issue: According to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device. To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device. The manufacturer Ziehm Imaging GmbH advised customers they may continue to operate the affected device with caution until the correction has been carried out on-site. During this time Ziehm Imaging GmbH advises the operator to be aware of the following safety measures which may resolve the possibility of potentially hazardous situations by: " Operating the power-off switch located either on the C-arm Stand top panel or on the monitor cart " Removing the power cable from the wall outlet or, " Activate the push-buttons for reverse vertical movement and keeping the pushbutton pressed until patient /operator is no longer in the risk zone or the device stops Please alert all staff members working with the device to these potential hazardous situations, and familiarize them with all possibilities to resolve the hazardous situation