Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
FDA device recall Z-1612-2015 · posted 2015-05-14 · Terminated
Recall details
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 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.
- 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 |