The Recall Desk
HighFDA (Devices)·Z-2111-2021·Announced 2021-07-28

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.

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 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
Category
Medical Device — Ultrasound Imaging Software
Hazard
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

Distributed in 5 states:

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