FDA recall Z-1199-2018

GE Healthcare, LLC · Class II · device

Product

DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.

Reason for recall

Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.

Distribution

US Distribution to states of: AZ, IL NC, NH and PA.

Key facts

Status
Terminated
Initiation date
2017-10-04
Report date
2018-04-04
Termination date
2020-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1199-2018