Z-2111-2021 Class II Terminated
FDA device recall Z-2111-2021 was initiated by Caption Health on May 19, 2021 and is designated Class II. 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… The recall status is terminated (terminated Jan 31, 2023). Affected quantity: 15 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 28, 2021
- Initiation Date
- May 19, 2021
- Termination Date
- Jan 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 systems
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)
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.
Distribution Pattern
US : AZ, DE, NY, IL, CT OUS: None
Code Information
All product containing software version 1.2.0
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2111-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026