Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201
FDA device recall Z-0976-2007 · posted 2007-06-28 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems LLC
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- IZH
- Quantity affected
- 106
- Distribution
- Worldwide, including USA, Germany, France, Italy, South Africa, Finland, Norway, Sweden, Venezuela, Benelux, Japan, China, and the UK.
- Date initiated
- 2005-11-16
- Date posted
- 2007-06-28
- Date terminated
- 2008-02-24
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) (K000976) | Instrumentarium Imaging, Inc. | 2000-06-01 |