Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GE Healthcare: a) Prodigy Recalled by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL Due to Under certain conditions, when using DICOM Worklist along...
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: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397 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: 303 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.
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