FDA recall Z-2963-2026

Product

GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.

Reason for recall

The module did not undergo electrical safety tests and functional tests during production.

Distribution

US Nationwide distribution in the states of CA, GA, MN, NY.

Key facts

Status

Ongoing

Initiation date

2026-06-30

Report date

2026-08-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Solna, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2963-2026