Recall Z-1611-2015 ยท DQK Computer, Diagnostic, Programmable
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
| Date | May 14, 2015 (initiated Feb 4, 2015) |
| Status | Terminated |
| 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 20 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023112 | PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 Problem Solving Concepts, Inc., Dec 17, 2002 |