Recall Z-1393-2018 ยท KGI Densitometer, Bone
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.
| Date | Mar 16, 2018 |
| Status | Terminated |
| Reason | Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS. |
| Root cause | Software design |
| Action | The firm initiated their recall by letter on March 16, 2018. The notice stated: "Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS. There have been no injuries reported as a result of this issue. You can continue using your system by disabling the DICOM MPPS feature as follows: 1. In enCORE, select Tools | Co |
| Quantity | 26 units |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Malta, Mexico, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030962 | DPX SERIES BRAVO DUO BONE DENSITOMETER Ge Lunar Corp., Jul 25, 2003 |