Home / Recalls / Fujifilm Medical Systems U.S.A., Inc. / Z-0073-2017

Z-0073-2017 Class II Terminated

Recalled by Fujifilm Medical Systems U.S.A., Inc. — Stamford, CT

Recall Details

Product Type: Devices
Report Date: October 19, 2016
Initiation Date: September 15, 2016
Termination Date: February 20, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 251 units

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

Distribution Pattern

US Nationwide Distribution.

Code Information

Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx

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