Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
FDA Recall Z-0976-2007 · Posted 2007-06-28
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Recalling FirmGeneral Electric Med Systems LLC
Recall StatusTerminated
Product CodeIZH
Date Initiated2005-11-16
Date Terminated2008-02-24
Product Quantity106
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Germany, France, Italy, South Africa, Finland, Norway, Sweden, Venezuela, Benelux, Japan, China, and the UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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