Device product
AS-OBGYN Information System version 7.824.x
Z-0118-2019
Product summary
- Event
- Event 81057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52 systems
- Official record key
device-enforcement:Z-0118-2019
Official wording
Reason: Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that ultrasound measurements are crossing over correctly to the AS system
Code information: Software version 7.824.x
Distribution pattern: US Nationwide.
Derived failure modes
-
Unknown
Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that ultrasound measurements are crossing over correctly to the AS system