FDA Medical Device Recalls (openFDA)
General Electric Med Systems LLC: Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
- Recall number
- Z-0976-2007
- Recalling firm
- General Electric Med Systems LLC
- Product
- Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
- Status
- Terminated
- Initiated
- 2005-11-16
- Posted
- 2007-06-28
- Terminated
- 2008-02-24
- Reason
- 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.
- 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
- 106
- Distribution
- Worldwide, including USA, Germany, France, Italy, South Africa, Finland, Norway, Sweden, Venezuela, Benelux, Japan, China, and the UK.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K000976"]
- PMA numbers
- not on file
- Product code
- IZH
- Firm FEI
- not on file
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28