Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2021 - (Recall #: Z-1775-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 30, 2021

Date Posted: June 9, 2021

Recall Number: Z-1775-2021

Event ID: 87938

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

Status: Terminated

Product Quantity: 44 US and 4 OUS

Code Information:

Software Versions: 6.0 to 6.2.1

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated