Z-0118-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 24, 2018
- Initiation Date
- September 20, 2018
- Termination Date
- April 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52 systems
Product Description
AS-OBGYN Information System version 7.824.x
Reason for Recall
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
Distribution Pattern
US Nationwide.
Code Information
Software version 7.824.x