Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
This recall has been terminated (originally issued April 15, 2016).
- Company
- Ziehm Imaging Inc
- Recall Initiated
- April 15, 2016
- Terminated
- July 18, 2019
- Recall Number
- Z-2642-2016
- Quantity
- 1 device
- Firm Location
- Orlando, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
Distribution
US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.
Lot / Code Info
Serial # 10841.
Root Cause
Device Design
Action Taken
Ziehm Imaging, Inc planned action to bring these defects into compliance: 1. You will contact customers and initiate a software update to correct the defects. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (866) 949-4346.