FDAMarch 16, 2018device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

ge medical systems ultrasound primary care diagnostics ll

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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