Z-1611-2015 Class II Terminated
FDA device recall Z-1611-2015 was initiated by Fujifilm Medical Systems U.S.A., Inc. on Feb 4, 2015 and is designated Class II. Reason for recall: Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report. The recall status is terminated (terminated Sep 20, 2018). Affected quantity: 30 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2015
- Initiation Date
- Feb 4, 2015
- Termination Date
- Sep 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
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
Reason for Recall
Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
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
Code Information
Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1611-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026