FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: 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
- Recall number
- Z-1612-2015
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Product
- 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
- Status
- Terminated
- Initiated
- 2015-02-04
- Posted
- 2015-05-14
- Terminated
- 2018-09-20
- Reason
- 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.
- Root cause
- Software in the Use Environment
- Action
- Fujifilm Medical on 2/4/14 , contacted users and advised to discontinue using HL7 reports pending FMSU determination of root cause. Firm issued follow-up letters on 2/24/14 and 7/24/14 advising users of a mandatory upgrade to version 5.1.1 I base, in-place upgrade, to correct the problems.
- Quantity
- 16 units
- Distribution
- 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.
- 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