FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versi
FDA device recall Z-1611-2015 · posted 2015-05-14 · Terminated
Recall details
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Reason for recall
- Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
- Action taken
- 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.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 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
- Date initiated
- 2015-02-04
- Date posted
- 2015-05-14
- Date terminated
- 2018-09-20
- Location
- Stamford, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 (K023112) | Problem Solving Concepts, Inc. | 2002-12-17 |