Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Summary
The FDA issued a Class II for Synapse CV 6. with AR. A web-based application as the primary user interface by FUJIFILM Healthcare Americas Corporation. Reason: 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.
Details
Source
Device Recall
External ID
Z-1172-2024
Action Date
2024-02-28
Status
Ongoing
Category
device
Product Description
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Lot/Code Info: UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0
Quantity Affected: 8
Reason for Recall
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.
Distribution
US domestic distribution nationwide. International distribution to Israel.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-03
Company
Lexington, MA
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 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
FUJIFILM Healthcare Americas Corporation has 36 FDA actions in our database, including 23 recalls and 13 clearances.
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 (FUJIFILM Healthcare Americas Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does FUJIFILM Healthcare Americas Corporation have FDA actions?
FUJIFILM Healthcare Americas Corporation has 36 FDA actions in our database, including 23 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1172-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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