FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: 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
- Recall number
- Z-1611-2015
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Product
- 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
- Status
- Terminated
- Initiated
- 2015-02-04
- Posted
- 2015-05-14
- Terminated
- 2018-09-20
- Reason
- Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
- Root cause
- Software in the Use Environment
- Action
- FujiMedical Systems North America issued intial recall letter dated February 4, 2014, advising users of the HL7 report exported to the EMR wherein measurement values presented in the Hl7 reports in your EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report. Follow-up letters were issued February 12, 2014, and July 24, 2014. A mandatory upgrade to software version 5.1.1/ base, in-place upgrade required. A customer response form attached to acknowledge receipt and arrange for the on site upgrade. For questions regarding this recall call 203-324-2000.
- Quantity
- 30 units
- Distribution
- Worldwide Distribution - US including CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI Foreign: Canada
- Lot, serial or model codes
- Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
- 510(k) numbers
- ["K023112"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 1000513161
- Firm city
- Stamford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28