FUJIFILM Healthcare Americas Corporation: Medical Device Recall in 2024 - (Recall #: Z-1171-2024)

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 Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. 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-1171-2024

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: 13

Code Information:

UDI-DI 854904006008 Software versions 7.3.000, 7.2.200, 7.2.100, 7.2.000, 7.1.000, 7.0.000

Distribution Pattern:

US domestic distribution nationwide. International distribution to Israel.

Voluntary or Mandated:

Voluntary: Firm initiated