The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1393-2018·Announced 2018-04-25

GE Healthcare Lunar DPX Duo and Bravo Bone Density Software Recall

GE Healthcare is recalling Lunar DPX Duo and Bravo bone density scanners because a software issue may cause reports to be filed under the wrong patient name in the hospital system.

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. The hazard involves incorrect patient data association in a medical record system, which is a significant data integrity issue but does not involve a direct physical injury mechanism or reported harm, fitting the Moderate severity criteria for labeling/data errors.

Plain-English summary

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC is recalling 26 units of the GE Healthcare Lunar DPX Duo (Model Number: LU41693) and DPX Bravo (Model Number: LU41692) bone density scanners. These devices are used to estimate bone mineral density at the lumbar spine and proximal femur regions. The recall covers units distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations.

The recall is due to a software issue involving the DICOM Worklist and DICOM MPPS. 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 displayed on the DICOM report image itself, the report may appear under a different patient's name in the PACS system.

Healthcare facilities that purchased these devices should contact GE Medical Systems for instructions on how to resolve the issue. Patients who have had bone density scans on these devices should consult their healthcare provider to verify that their records are correctly associated with their identity.

The recalled product

Product
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…
Manufacturer
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Category
Medical Device — Imaging / Diagnostic
Hazard
Affected units
26

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 (3)

  • a) DPX Duo
  • Model Number: LU41693 b) DPX Bravo
  • Model Number: LU41692

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 →

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