Recall Z-1612-2015 ยท DQK Computer, Diagnostic, Programmable
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
| Date | May 14, 2015 (initiated Feb 4, 2015) |
| Status | Terminated |
| 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. |
| 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 |