Fujifilm Medical Systems U.S.A., Inc. Recall 87938
Description: Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Fujifilm Medical Systems U.S.A., Inc. Recall 87938 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1775-2021 |
| Event ID | 87938 |
| Event Description | Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center. |
| Quantity | 44 US and 4 OUS |
| Recall Reason | Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence |
| Device Classification | 20210609 |
| Device Code Info | Software Versions: 6.0 to 6.2.1 |
| Center Classification Date | 20210602 |
| Recall Initiation Date | 20210430 |
| Recalling Firm | Fujifilm Medical Systems U.S.A., Inc. |
| Initial Notification | |
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