Z-1394-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 25, 2018
- Initiation Date
- March 16, 2018
- Termination Date
- December 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43 units
Product 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.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352