Recall Z-2144-2008 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE Healthcare
GE Precision MPi, model 2398238. GE Medical Systems - Americas, Milwaukee, USA The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.
| Date | Sep 19, 2008 (initiated May 1, 2008) |
| Status | Terminated |
| Reason | The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Field Engineers visited affected customers to make the correction. |
| Quantity | 54 (24 US / 30 OUS) |
| Distribution | Within the US to include: CA, CO, FL, IN, MA, MN, NV, NY, OR, PA, TN, VT, WA, and WI. OUS to include: CANADA, GERMANY, ITALY, POLAND, SAUDI ARABIA, SLOVAKIA, SPAIN, TURKEY, and UNITED KINGDOM, |
| 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 |