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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
Brand
General Electric Med Systems LLC
Lot Codes / Batch Numbers
Model 5111771 (foreign) 116, 117, 135, 171, 175, 208, 209, 212, 215, 156, 106, 214, 211, 120, 169, 125, 119, 210, 126, 124, 139, 196, 140, 218, 121, 197, 213, 216, 170, 217, 185, 195, 152, 174, 130, 173, 138 (USA) 155, 167, 172, 176, 182, 051, 101, 118, 122, 123, 127, 128, 129, 131, 132, 133, 134, 136, 137, 141-151, 153, 154, 157-166, 177-181, 183, 184, 186-194, 198-207, 219.
Products Sold
Model 5111771 (foreign) 116, 117, 135, 171,175, 208, 209, 212, 215, 156, 106, 214, 211, 120, 169, 125, 119, 210, 126, 124, 139, 196, 140, 218, 121, 197, 213, 216, 170, 217, 185, 195, 152, 174, 130, 173, 138 (USA) 155, 167, 172, 176, 182, 051, 101, 118, 122, 123, 127, 128, 129, 131, 132, 133, 134, 136, 137, 141-151, 153, 154, 157-166, 177-181, 183, 184, 186-194, 198-207, 219.
General Electric Med Systems LLC is recalling Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwa due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026