The Recall Desk
HighFDA (Devices)·Z-1230-2022·Announced 2022-06-15

Medical imaging software distance and area measurements may display inaccurately

Centricity Enterprise Web medical imaging software may display inaccurate distance and area measurements when processing magnified or scaled images. The software is distributed to healthcare facilities worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall. The software's potential measurement inaccuracies could affect diagnostic accuracy in clinical imaging. This risk-of-harm scenario meets the rubric criterion for High severity.

Plain-English summary

GE Healthcare, LLC is recalling the Centricity Enterprise Web medical imaging software due to potential measurement inaccuracies. The software may display inaccurate distance and area measurements when these measurements are performed on magnified images. Additionally, when using the ZFP feature, the software may display inaccurate measurements when performed on lossy images that have been scaled down from their original resolution. Approximately 536 units have been distributed worldwide, including nationwide distribution across all U.S. states and to dozens of international countries. Affected healthcare facilities and practitioners should contact GE Healthcare for further information regarding remediation.

The recalled product

Product
Centricity Enterprise Web
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging Software
Hazard
Affected units
536

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 (5)

  • Software Versions 3.0 through 3.0 SP14d
  • 4.0 through 4.0 Spa6c and 4.0 Spa7b
  • Codes: 2027870-0XX
  • 2049944-0XX
  • 2068692-0XX.

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare, LLC 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 5 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · measurement inaccuracy

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