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 Insight

This FDA Devices action (record #Z-1394-2018) was formally reported on April 25, 2018, with the manufacturer initiating the action on March 16, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. GE Medical Systems Ultrasound & Primary Care Diagnostics, LL is listed as the recalling firm, operating out of Madison, WI. Federal records indicate 43 units units are affected.

The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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 Kon…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.