Home / Recalls / Fujifilm Medical Systems U.S.A., Inc. / Z-1775-2021

Z-1775-2021 Class II Terminated

Recalled by Fujifilm Medical Systems U.S.A., Inc. — Lexington, MA

Recall Details

Product Type
Devices
Report Date
June 9, 2021
Initiation Date
April 30, 2021
Termination Date
July 29, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44 US and 4 OUS

Product Description

Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system

Reason for Recall

Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center.

Code Information

Software Versions: 6.0 to 6.2.1

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