Version: 1.2.0 recall: Software Issue
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI…
Why was Version: 1.2.0 recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All product containing software version 1.2.0
- Product
- Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI…
- Recalling firm
- Caption Health
- Quantity
- 15 systems
- Distribution
- US : AZ, DE, NY, IL, CT OUS: None
- Recall date
- July 28, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)