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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2111-2021 |
| Event ID | 88101 |
| Event 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) |
| Product Type | Devices |
| Distribution | US : AZ, DE, NY, IL, CT OUS: None |
| Quantity | 15 systems |
| Recall 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 automated ejection fraction (AutoEF) and image quality score (IQS) estimates. |
| Device Classification | 20210728 |
| Device Code Info | All product containing software version 1.2.0 |
| Center Classification Date | 20210722 |
| Recall Initiation Date | 20210519 |
| Recalling Firm | Caption Health |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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