medical Class II Updated 2020-11-11

GE Healthcare, LLC recalls Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Affected States: 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
Lot/Code Info: Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)
View official government recall

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