Centricity Cardiology CA1000 may display inaccurate distance and area measurements
GE Healthcare is recalling the Centricity Cardiology CA1000 software due to potential inaccurate distance and area measurements on magnified or scaled-down images, which could affect diagnostic accuracy.
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: This is a Class II medical device recall involving software that affects diagnostic measurements in cardiology imaging. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High), and the potential for inaccurate diagnostic measurements qualifies as a risk-of-harm scenario.
Plain-English summary
GE Healthcare, LLC is recalling 601 units of the Centricity Cardiology CA1000 software due to a potential for measurement inaccuracy in distance and area calculations. The software may display incorrect distance and area measurements when these calculations are performed on magnified images. Additionally, for ZFP functionality specifically, inaccurate measurements can occur when performed on lossy images that have been scaled down from their original resolution.
The software has been distributed worldwide and throughout all U.S. states, as well as in multiple international locations. Users of this software should refer to the official FDA recall notice for detailed information about remediation options and next steps.
The recalled product
- Product
- Centricity Cardiology CA1000
- Manufacturer
- GE Healthcare, LLC
- Hazard
- measurement-inaccuracy
- diagnostic-error-risk
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)
- a. Software Version 1.0 through 1.0 SP
- No GTIN/DI (Code: 2022296-0XX)
- b. Software Version 2.0 through 2.0 SP14H
- GTIN/DI: 00840682125260 (Codes: 2038437-0XX
- 2097190-0XX)
Distribution
Distributed nationwide across the United States.
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