RecallRadar

FDA Device recall Z-1199-2018

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

On 2018-04-04 the FDA classified a Class II recall of DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent by Ge Healthcare, citing non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1199-2018
ClassificationClass II
Statusterminated
Initiated2017-10-04
Published2018-04-04
Last updated2026-09-13 11:54 UTC
CompanyGe Healthcare
DistributionAZ, IL, NC, NH, PA

Product

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

Reason

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

Identifiers

code_infoModel 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1199-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.