Z-0311-2021Class II

Aestiva/5 MRI Anesthesia System -

Name: Z-0311-2021 Aestiva/5 MRI Anesthesia System -
Creator: GE Healthcare, LLC
Published: 2020-09-17
License: https://open.fda.gov/license/

GE Healthcare / initiated 2020-09-17 / Open, Classified / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5... on 2020-09-17. FDA classified it as Class II and gives the reason as "Flow sensors could have damaged tubes in the form of small punctures or cuts". 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-0311-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-17
Posted: 2020-10-30
Recalling firm: GE Healthcare
Product: Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Flow sensors could have damaged tubes in the form of small punctures or cuts.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: GE will issue an Urgent Medical Device Correction letter to customers with affected flow sensors. This letter will inform the customer of the issue and provide safety instructions, including to inspect all inventory of Flow Sensors. GE Healthcare will replace the Flow Sensors indicated on returned customer response forms, if applicable. In the U.S., this letter will be sent by a traceable means. The letter will be sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the replacement of Flow Sensors, if needed.
Quantity in commerce: 2 devices
Distribution: U.S. states where product was distributed - AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI Foreign countries impacted - Australia, Canada, Czech Republic, Estonia, France, Germany, India, Indonesia, Israel, Italy, Kuwait, Latvia, Macedonia, Madagascar, Malaysia, Nicaragua, Panama, Qatar, Russia, Singapore, Slovenia, Spain, Thailand, Ukraine, United Kingdom
Product codes and lots: Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0311-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0311-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-11	2020-10-30
Z-0312-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-11	2020-10-30
Z-0313-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-11	2020-10-30
Z-0314-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-11	2020-10-30
Z-0315-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-11	2020-10-30
Z-0316-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-11	2020-10-30
Z-0317-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-11	2020-10-30

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)