GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 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.
Recall
- Recall Number
- Z-1394-2018
- Event Number
- 79710
- Firm
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
- FEI Number
- 2183066
- Product Code
- KGI
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- March 16, 2018
- Terminated
- December 14, 2020
- Address
- 3030 Ohmeda Dr, Madison, WI, 53718-6704
Description
GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 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.
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.
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 | Connectivity Options. 2. Select DICOM tab. 3. Press Configure Connections in DICOM Worklist section. 4. In the MPPS SCP Settings, clear the AE Title and the TCP/IP Address fields 5. Press OK to all. A GE Healthcare representative will contact you to arrange for the correction." For further questions, please call (608) 826-7492
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, Morocco, Norway, Poland, Portugal , Romania, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab, United Kingdom and Venezuela.
43 units