Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873)
Summary
The FDA issued a Class II for Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging S by Caption Health. Reason: The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect autom.
Details
Source
Device Recall
External ID
Z-2111-2021
Action Date
2021-07-28
Status
Terminated
Category
device
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)
Lot/Code Info: All product containing software version 1.2.0
Quantity Affected: 15 systems
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
US : AZ, DE, NY, IL, CT OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-19
Company
Brisbane, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Caption Health has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Caption Health) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Caption Health have FDA actions?
Caption Health has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2111-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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