Z-0118-2019 Class II Terminated
FDA device recall Z-0118-2019 was initiated by AS Software, Inc. on September 20, 2018 and is designated Class II. 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 enviro… The recall status is terminated (terminated April 19, 2019). Affected quantity: 52 systems.
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