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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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.
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