Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2015 - (Recall #: Z-1612-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable

Product Classification:

Class II

Date Initiated: February 4, 2015

Date Posted: May 20, 2015

Recall Number: Z-1612-2015

Event ID: 70890

Reason for Recall:

Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report.

Status: Terminated

Product Quantity: 16 units

Code Information:

Software Versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1

Distribution Pattern:

Nationwide Distribution including PR and the states of IL, IN, FL, GA, MD, MI, MO, MS, NC, NY, OR, and PA, PR and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated