Z-1199-2018Class II

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

Name: Z-1199-2018 DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent
Creator: GE Healthcare, LLC
Published: 2017-10-04
License: https://open.fda.gov/license/

GE Healthcare / initiated 2017-10-04 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent on 2017-10-04. FDA classified it as Class II and gives the reason as "Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1199-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-04
Posted: 2018-03-26
Terminated: 2020-04-10
Recalling firm: GE Healthcare
Product: DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, GE healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 4th, 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact GE Service to obtain an RMA number. GE Healthcare has arranged with Piramal Inc. to replace the affected products at no cost. If you have any questions or concern regarding this notification please contact GE healthcare Service at 1-800-437-1171 or your local representative.
Quantity in commerce: 2
Distribution: US Distribution to states of: AZ, IL NC, NH and PA.
Product codes and lots: Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1199-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1198-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26
Z-1199-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26

Product code BSZ

K170872Class IIAisys CS2Datex-Ohmeda, Inc. / cleared 2017-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)