Recall Z-2641-2016 ยท OWB Interventional Fluoroscopic X-Ray System
Ziehm Imaging Inc
Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
| Date | Apr 15, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 2 devices |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083545 | ZIEHM VISION RFD Ziehm Imaging, Inc., May 15, 2009 |