Company:GE Medical Systems Ultrasound & Primary Care Diagnostics,
Date of Enforcement Report 4/25/2018
Class lI:
PRODUCT
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, LU42397Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions.
Recall Number Z-1395-2018
REASON
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
RECALLING FIRM/MANUFACTURER
GE Medical Systems Ultrasound & Primary Care Diagnostics, Madison, WI on 3/16/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
303 units
DISTRIBUTION
Worldwide
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