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U.S. Department of Health and Human Services

Class 2 Device Recall Caption Interpretation Auto Ejection Fraction Software

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  Class 2 Device Recall Caption Interpretation Auto Ejection Fraction Software see related information
Date Initiated by Firm May 19, 2021
Create Date July 22, 2021
Recall Status1 Terminated 3 on January 31, 2023
Recall Number Z-2111-2021
Recall Event ID 88101
510(K)Number K200621  
Product Classification Automated Radiological Image Processing Software - Product Code QIH
Product 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)
Code Information All product containing software version 1.2.0
Recalling Firm/
Manufacturer		 Caption Health
2000 Sierra Point Pkwy Fl 8
Brisbane CA 94005-1845
For Additional Information Contact Caption health Support
1855-506-4357
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action On May 19, 2021 Caption health, Inc. contacted consignees via telephone to inform them about their recall. On May 20, 2021, the firm sent follow-up communication via via email. In addition to informing consignees about the recall, the firm also asked customers to take the following actions: 1. Until your system is updated, we recommend that all EF calculations are reviewed carefully using clinical expertise, to verify the accuracy of the results. 2. If you have any questions or concerns, please contact Caption health support line at 1-855-506-HELP between 7am-7pm ET. You can also email us at support@captionhealth.com at any time. We will follow-up with additional details relevant to your site by Monday May 24
Quantity in Commerce 15 systems
Distribution US : AZ, DE, NY, IL, CT OUS: None
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = QIH and Original Applicant = Caption Health
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