Ultrasound Imaging Software Recalled for Inaccurate Measurement Estimates
Caption Health recalled ultrasound imaging software version 1.2.0 due to a bug that includes unintended video frames in its analysis, potentially resulting in incorrect automated ejection fraction and image quality score estimates. The recall affects approximately 15 systems distributed across five U.S. states.
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 with a software bug that could produce inaccurate cardiac measurements. No illnesses, injuries, or hospitalizations have been reported. The potential for diagnostic error exists but has not yet resulted in documented harm.
Plain-English summary
Caption Health has recalled version 1.2.0 of its Caption AI ultrasound imaging system software. The software contains a bug that results in unintended video frames being included in analysis, potentially causing incorrect automated ejection fraction (AutoEF) and image quality score (IQS) estimates.
Approximately 15 systems using this software version are in use across five U.S. states: Arizona, Delaware, New York, Illinois, and Connecticut. The software's automated measurement calculations could produce inaccurate results.
Users of affected systems should contact Caption Health regarding this recall to learn about available remediation options.
The recalled product
- Product
- Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
- Manufacturer
- Caption Health
- Affected units
- 15
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 (1)
- All product containing software version 1.2.0
Distribution
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