FUJIFILM Healthcare Americas Corporation: Medical Device Recall in 2024 - (Recall #: Z-1172-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

Product Classification:

Class II

Date Initiated: January 3, 2024

Date Posted: February 28, 2024

Recall Number: Z-1172-2024

Event ID: 93855

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.

Status: Ongoing

Product Quantity: 8

Code Information:

UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0

Distribution Pattern:

US domestic distribution nationwide. International distribution to Israel.

Voluntary or Mandated:

Voluntary: Firm initiated