Device product
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
Z-2865-2016
Product summary
- Event
- Event 75034
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42 sites potentially have the affected version
- Official record key
device-enforcement:Z-2865-2016
Official wording
Reason: Patient information in the header is only found on the first page of the report and not on the subsequent pages.
Code information: Version 10.1
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Patient information in the header is only found on the first page of the report and not on the subsequent pages.