FDA recall Z-2954-2018

Product

GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems

Reason for recall

On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia.

Distribution

Worldwide

Key facts

Status

Terminated

Initiation date

2018-07-24

Report date

2018-09-05

Termination date

2020-12-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wuxi, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2954-2018