Recall Z-2123-2015 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE Healthcare
GE Healthcare, Precision MPi fluoroscopic imaging systems.
| Date | Jul 20, 2015 (initiated Jun 12, 2015) |
| Status | Terminated |
| Reason | A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems. |
| Root cause | Nonconforming Material/Component |
| Action | GE Healthcare sent an "Urgent Medical Device Correction" letter dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Perform a visual check before and after each use for the presence of the four (4) mounting screws as shown in the pictures below. Check the secureness of these screws by hand. If these screws are present and secure, you may continue use of the system. If any of these screws are missing or can easily be turned by hand, follow the precautions below before you continue use with the monitor |
| Quantity | 788 (701 US; 87 OUS) |
| Distribution | Worldwide Distribution - US Nationwide Distribution including GU and DC., and to the countries of : Australia, Bulgaria, Canada, Chile, Dominican Republic, Germany, Ireland, Italy, Kuwait, Lebanon, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Spain, Taiwan,Turkey, United Kingdom, Venezuela an |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033486 | GE PRECISION MPI Nrt-Nordisk Rontgen Teknik A/S, Nov 19, 2003 |