Recall Z-1171-2024— FUJIFILM Healthcare Americas Corporation

Name: FDA recall Z-1171-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-03

Class II · Ongoing

Class II FDA medical device recall by FUJIFILM Healthcare Americas Corporation, initiated 2024-01-03. It names one FDA 510(k) clearance: K190232. Product: 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.. 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 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..

Recalling firm: FUJIFILM Healthcare Americas Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-01-03
Firm location: Lexington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K190232 — Synapse PACSFujifilm Corporation·cleared 2019-03-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.