Recall Z-2471-2020— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-2471-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-22

Class II · Ongoing

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2020-05-22. It names one FDA 510(k) clearance: K160108. Product: Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server). Reason: Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis.

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-05-22
Firm location: Lexington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K160108 — Synapse PACSFujifilm Medical Systems U.S.A, Inc.·cleared 2016-02-03

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 Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)

Reason for recall

Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis

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