FDA Device recall Z-1611-2015
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular
- FDA Device
- Class II
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class II recall of FujiMedical Synapse Cardiovascular I ProSolv CardioVascular by Fujifilm Medical Systems U, citing measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1611-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-04 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI |
Product
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
Reason
Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
Identifiers
| code_info | Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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- Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1611-2015%22
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