FDA recall Z-1775-2021

Fujifilm Medical Systems U.S.A., Inc. · Class II · device

Product

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

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

Key facts

Status: Terminated
Initiation date: 2021-04-30
Report date: 2021-06-09
Termination date: 2024-07-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1775-2021