Device product
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Z-1775-2021
Product summary
- Event
- Event 87938
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44 US and 4 OUS
- Official record key
device-enforcement:Z-1775-2021
Official wording
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
Code information: Software Versions: 6.0 to 6.2.1
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center.
Derived failure modes
-
Device software or design
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can