Z-1612-2015 Class II Terminated
FDA device recall Z-1612-2015 was initiated by Fujifilm Medical Systems U.S.A., Inc. on Feb 4, 2015 and is designated Class II. 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. The recall status is terminated (terminated Sep 20, 2018). Affected quantity: 16 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
- 16 units
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
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.
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.
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-1612-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026