Centricity Radiology RA600 displays inaccurate distance and area measurements on magnified images
GE Healthcare's Centricity Radiology RA600 medical imaging software displays inaccurate distance and area measurements when performed on magnified images. Affected systems include worldwide installations of approximately 1,332 units.
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 with potential for inaccurate diagnostic measurements on magnified and lossy images. No illnesses or injuries have been reported; the hazard is theoretical but could affect clinical decision-making if measurements are relied upon without verification.
Plain-English summary
GE Healthcare, LLC has issued a recall for the Centricity Radiology RA600, a medical imaging software system. The software can display inaccurate measurement values when distance and area measurements are performed on magnified images. For the ZFP version specifically, the software can also display inaccurate measurements on lossy images that have been scaled down from their original resolution.
The recall affects approximately 1,332 units distributed worldwide, including installations across all U.S. states and territories as well as internationally. Inaccurate measurement displays in medical imaging software could compromise diagnostic accuracy and reliability.
Healthcare facilities using affected systems should contact GE Healthcare for information regarding this recall and potential remediation options.
The recalled product
- Product
- Centricity Radiology RA600
- Manufacturer
- GE Healthcare, LLC
- Hazard
- measurement-inaccuracy
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 7.0 through 7.0 SP
- No GTIN/DI (Code: 2022296-0XX)
- b. Software Version 8.0 through 8.0 SP14H
- GTIN/DI: 00840682125260 (Codes: 2038437-0XX
- 2097190-0XX)
Distribution
Distributed nationwide across the United States.
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