Z-1427-2022Class II

GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia...

Name: Z-1427-2022 GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia...
Creator: GE Healthcare, LLC
Published: 2022-05-27
License: https://open.fda.gov/license/

GE Healthcare / initiated 2022-05-27 / Open, Classified / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000 on 2022-05-27. FDA classified it as Class II and gives the reason as "The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1427-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-27
Posted: 2022-07-20
Recalling firm: GE Healthcare
Product: GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm issued letters dated 5/27/2022 via traceable means on 5/27/2022 which were addressed to the Director of Respiratory, Chief of Anesthesia, Health Care Administrator/Risk Manager, and Director of Biomedical/Clinical Engineering. The letter is flagged that the consignee needs to ensure all potential users in the facility are made aware of this safety notification and recommended actions. The notification informs the consignees of the affected devices, the safety issue, and actions to be taken. The actions notified the consignee they can continue to use the anesthesia system by following instructions listed in the letter. The instructions were to inspect the anesthesia system for cracks at the rear of the base as depicted in the diagram and photograph, and if no cracks are observed, they can continue to use the anesthesia system. If a crack at the rear is observed, they can continue to use the system under the following conditions: Limit the movement of the system using care on uneven flooring/threshold and ensure the floor is clear of obstacles (cables, power cords, etc.); and do not exceed the recommended weight limit for equipment mounted or supported by the anesthesia system. A Medical Device Notification Acknowledgement Response form was to be completed and returned within 30 days of receipt to acknowledge receipt and understanding of the notification. The letter informs the consignee that the recalling firm will inspect all affected devices at no cost and that a firm representative will contact the consignee to arrange for the correction.
Quantity in commerce: 667 devices
Distribution: Distribution was made to AZ, CA, CO, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MT, NC, NE, NV, NY, OH, PA, SC, TN, TX, VA, and WV. There was also military distribution but no government distribution. Foreign distribution was made to Australia, Canada, China, Estonia, Finland, France, Germany, Greece, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Korea, Malaysia, New Zealand, Philippines, Romania, Russia, Saudi Arabia, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Product codes and lots: Avance CS2 and Avance CS2 Pro - GTIN 00840682102322, all serial numbers; Aisys CS2 - GTIN 00840682102292, all serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1427-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1427-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-20

Product code BSZ

K172045Class IIAestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2Datex-Ohmeda, Inc. / cleared 2017-11-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)