Product Safety Recalls

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Caption Health Recall 88101

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)

Caption Health Recall 88101 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2111-2021
Event ID88101
Event DescriptionVersion: 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)
Product TypeDevices
DistributionUS : AZ, DE, NY, IL, CT OUS: None
Quantity15 systems
Recall ReasonThe 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.
Device Classification20210728
Device Code InfoAll product containing software version 1.2.0
Center Classification Date20210722
Recall Initiation Date20210519
Recalling FirmCaption Health
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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