Recall Z-0878-2021— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-0878-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-11

Class II · Ongoing

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2020-09-11. It names one FDA 510(k) clearance: K160108. Product: Synapse PACS Software Versions 5.1 and higher. Reason: There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality..

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-09-11
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

Synapse PACS Software Versions 5.1 and higher

Reason for recall

There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.

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