FDA recall Z-0118-2019

Product

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

US Nationwide.

Key facts

Status

Terminated

Initiation date

2018-09-20

Report date

2018-10-24

Termination date

2019-04-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Englewood Cliffs, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2019