Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GE Healthcare Lunar: a) DPX Duo Recalled by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL Due to Under certain conditions, when using DICOM Worklist along...

Date: March 16, 2018
Company: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Medical Systems Ultrasound & Primary Care Diagnostics, LL directly.

Affected Products

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 discretion of the physician.

Quantity: 26 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL has 12 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report