Recall Z-0976-2007 ยท IZH System, X-Ray, Mammographic
General Electric Med Systems LLC
Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
| Date | Jun 28, 2007 (initiated Nov 16, 2005) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of the absence of thread-locking compound associated with the C-arm fasteners of your Diamond mammographic x-ray system that may impact patient safety. |
| Root cause | Other |
| Action | A Product Safety Notification, dated 05/24/07, was sent to Hospital Administrators, Managers of Radiology and Radiologists. This letter describes the safety issue, instructions to continue the use of the product and states that the device will be corrected by GE Healthcare service engineers. |
| Quantity | 106 |
| Distribution | Worldwide, including USA, Germany, France, Italy, South Africa, Finland, Norway, Sweden, Venezuela, Benelux, Japan, China, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000976 | DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) Instrumentarium Imaging, Inc., Jun 1, 2000 |