Recall Z-0603-2010 ยท KGI Densitometer, Bone
Ge Healthcare
DPX-MD series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD.
| Date | Jan 27, 2010 (initiated Feb 1, 2009) |
| Status | Terminated |
| Reason | Failure to properly pre-indicate the technique factors to be used during a patient scan. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | An Important Electronic Product Radiation Warning letter will be sent to customers. The letter will discuss the defect description and related hazards, the affected product details, safety instructions, and product correction. Customers are to contact their local GE Healthcare service representative with questions. |
| Quantity | 1,764 total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.