Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2015 - (Recall #: Z-1611-2015)

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:

FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1

Product Classification:

Class II

Date Initiated: February 4, 2015

Date Posted: May 20, 2015

Recall Number: Z-1611-2015

Event ID: 70891

Reason for Recall:

Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.

Status: Terminated

Product Quantity: 30 units

Code Information:

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

Distribution Pattern:

Worldwide Distribution - US including CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI Foreign: Canada

Voluntary or Mandated:

Voluntary: Firm initiated