Company:GE Medical Systems Ultrasound & Primary Care Diagnostics,
Date of Enforcement Report 4/25/2018
Class lI:
PRODUCT
1. 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.
2. GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 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
Recall Number Z-1393-2018 and Z-1394-2018
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
1. 26 units
2. 43 units
DISTRIBUTION
Worldwide
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