GE Healthcare, LLC: Medical Device Recall in 2020 - (Recall #: Z-0311-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 17, 2020

Date Posted: November 11, 2020

Recall Number: Z-0311-2021

Event ID: 86531

Reason for Recall:

Flow sensors could have damaged tubes in the form of small punctures or cuts.

Status: Ongoing

Product Quantity: 2 devices

Code Information:

Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated