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 January 31, 2023). Affected quantity: 15 systems.
Recall Details
- Product Type
- Devices
- Report Date
- July 28, 2021
- Initiation Date
- May 19, 2021
- Termination Date
- January 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