Z-0976-2007

Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee...

Name: Z-0976-2007 Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee...
Creator: General Electric Med Systems LLC
Published: 2005-11-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2005-11-16 / Terminated

FDA source

General Electric Med Systems LLC began a recall of Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A on 2005-11-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0976-2007
Status: Terminated
Initiated: 2005-11-16
Posted: 2007-06-28
Terminated: 2008-02-24
Recalling firm: GE Healthcare
Product: Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
Product code: IZH System, X-Ray, Mammographic
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 root cause: Other
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.
Product codes and lots: 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 code IZH

K000976Class IIDiamond (Mammographic X-Ray System)Instrumentarium Imaging, Inc. / cleared 2000-06-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)