Recall Z-1395-2018— GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Name: FDA recall Z-1395-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-16

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, initiated 2018-03-16, terminated 2020-12-14. It names one FDA 510(k) clearance: K982267. 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, 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.. 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: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Classification: Class II
Status: Terminated
Initiated: 2018-03-16
Terminated: 2020-12-14
Firm location: Madison, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K982267 — DPX-RX BONE DENSITOMETERLunar Corp.·cleared 1998-08-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.