Recall Z-0918-2021— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-0918-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-11

Class II · Terminated

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2020-12-11, terminated 2021-11-17. It names one FDA 510(k) clearance: K190232. Product: FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.. Reason: The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user..

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-12-11
Terminated: 2021-11-17
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

FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.

Reason for recall

The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.

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