medical Class II Updated 2018-04-25

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL recalls GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b)

Recalled 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 discretion of the physician.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692
View official government recall

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