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U.S. Department of Health and Human Services

Class 2 Device Recall Diamond Mammographic XRay System

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 Class 2 Recall
Diamond Mammographic XRay System
see related information
Date Posted June 28, 2007
Recall Status1 Terminated on February 24, 2008
Recall Number Z-0976-2007
Recall Event ID 37651
Premarket Notification
510(K) Number
K000976 
Product Classification System, X-Ray, Mammographic - Product Code IZH
Product Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
Code Information 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.
Recalling Firm/
Manufacturer
General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
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 in Commerce 106
Distribution Worldwide, including USA, Germany, France, Italy, South Africa, Finland, Norway, Sweden, Venezuela, Benelux, Japan, China, and the UK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZH and Original Applicant = INSTRUMENTARIUM IMAGING, INC.
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