Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1394-2018 — 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

U.S. FDA — Device Enforcement · United States · 2018-03-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1394-2018
Date of alert: 2018-03-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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