Caption Health: Medical Device Recall in 2021 - (Recall #: Z-2111-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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)

Product Classification:

Class II

Date Initiated: May 19, 2021

Date Posted: July 28, 2021

Recall Number: Z-2111-2021

Event ID: 88101

Reason for Recall:

The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoEF) and image quality score (IQS) estimates.

Status: Terminated

Product Quantity: 15 systems

Code Information:

All product containing software version 1.2.0

Distribution Pattern:

US : AZ, DE, NY, IL, CT OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated