Synapse CV 6. with AR. A web-based application as the recall
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Why was Synapse CV 6. with AR. A web-based application as the recalled?
The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0
- Product
- Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Quantity
- 8
- Distribution
- US domestic distribution nationwide. International distribution to Israel.
- Recall date
- February 28, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)