Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
This recall has been terminated (originally issued June 28, 2007).
- Company
- General Electric Med Systems Llc
- Recall Initiated
- November 16, 2005
- Posted
- June 28, 2007
- Terminated
- February 24, 2008
- Recall Number
- Z-0976-2007
- Quantity
- 106
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide, including USA, Germany, France, Italy, South Africa, Finland, Norway, Sweden, Venezuela, Benelux, Japan, China, and the UK.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.