The Recall Desk
ModerateFDA (Devices)·Z-1395-2018·Announced 2018-04-25

GE Healthcare Prodigy Ultrasound Recall for Incorrect Patient Data in Reports

GE Healthcare is recalling Prodigy and Prodigy Advanced ultrasound systems because bone density exam reports may be sent to PACS with incorrect patient information in the DICOM header.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall involves a data integrity issue where reports may be associated with the wrong patient in the PACS system, but the correct data is present on the image itself. This is a moderate risk of administrative error or misdiagnosis due to data mismatch, but does not involve direct physical injury or a high-risk pathogen.

Plain-English summary

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC is recalling 303 units of GE Healthcare Prodigy and Prodigy Advanced ultrasound systems. The affected models include Prodigy (LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365) and Prodigy Advanced (LU42361, LU42397). These devices provide estimates of bone mineral density at the lumbar spine and proximal femur regions.

The recall is due to a software issue where, under certain conditions, using DICOM Worklist along with DICOM MPPS may cause a bone density exam report to be sent to the Picture Archiving and Communication System (PACS) with incorrect patient information in the DICOM header. While the correct patient information is listed on the DICOM report image itself, the report may appear under a different patient's name in the PACS system.

The affected units were distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international countries. Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue and ensure patient data integrity.

The recalled product

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 t
Manufacturer
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Category
Medical Device — Ultrasound Systems
Hazard
Affected units
303

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • a) Prodigy
  • Model Numbers: LU7248
  • LU8905
  • LU40427
  • LU40431
  • LU40626
  • LU40637
  • LU42021
  • LU42025
  • LU41730
  • LU41734
  • LU42344
  • LU42365 b) Prodigy Advanced
  • Model Numbers: LU42361
  • LU42397

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

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Same hazard · data integrity

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