Z-0918-2021 Class II Terminated
FDA device recall Z-0918-2021 was initiated by Fujifilm Medical Systems U.S.A., Inc. on December 11, 2020 and is designated Class II. 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. The recall status is terminated (terminated November 17, 2021). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- February 3, 2021
- Initiation Date
- December 11, 2020
- Termination Date
- November 17, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
Distribution Pattern
US Nationwide distribution in the state of MD.
Code Information
Versions 7.0.0 and 7.0.1