FDA recall Z-1691-2021

Product

Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.

Reason for recall

Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning

Distribution

US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.

Key facts

Status

Terminated

Initiation date

2021-04-16

Report date

2021-06-09

Termination date

2024-02-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1691-2021