The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1394-2018·Announced 2018-04-25

GE Healthcare Lunar DPX Bone Density Systems Recalled for Data Errors

GE Healthcare is recalling 43 Lunar DPX bone density systems because patient reports may be sent to hospital systems with incorrect names in the header.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a data integrity error (mislabeling of patient records) rather than a direct physical injury or high-risk pathogen, fitting the Moderate criteria for minor labeling or data errors.

Plain-English summary

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC is recalling 43 units of the GE Healthcare Lunar DPX NT and DPX MD+ bone density systems. The affected model numbers are LU8230, LU40338, LU42357, LU42369, and LU40352. These devices provide estimates of bone mineral density at the lumbar spine and proximal femur regions.

The recall is due to a software issue where, under certain conditions, a report for a bone density exam may be sent to the Picture Archiving and Communication System (PACS) with incorrect patient information in the DICOM header. While the correct patient information is listed on the DICOM report image itself, the report may appear under a different patient's name in the PACS system.

The affected units were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international locations. No specific instructions for consumers are provided in the source text, but the issue affects the administrative handling of patient data within medical imaging systems.

The recalled product

Product
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…
Manufacturer
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
43

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • a) DPX NT
  • Model Numbers: LU8230
  • LU40338
  • LU42357
  • LU42369 b) DPX MD+
  • Model Numbers: LU8230
  • LU40352

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

See all →

Same hazard · data integrity

See all →

Similar recalls