Recall Z-0073-2017— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-0073-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-15

Class II · Terminated

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2016-09-15, terminated 2019-02-20. It names one FDA 510(k) clearance: K112439. Product: Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities. Reason: Image data for a patients image may not be correct.

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-09-15
Terminated: 2019-02-20
Firm location: Stamford, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K112439 — SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0Fujifilm Medical System U.S.A., Inc.·cleared 2011-10-17

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: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities

Reason for recall

Image data for a patients image may not be correct

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