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Devices
Device Recall Diamond Mammographic XRay System
Model / Serial
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.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Germany, France, Italy, South Africa, Finland, Norway, Sweden, Venezuela, Benelux, Japan, China, and the UK.
Product Description
Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
Manufacturer
General Electric Med Systems LLC
1 Event
Recall of Device Recall Diamond Mammographic XRay System
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Manufacturer
General Electric Med Systems LLC
Manufacturer Address
General Electric Med Systems LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
Source
USFDA
Language
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