medical Class II Updated 2020-11-11

GE Healthcare, LLC recalls GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage:

Recalled Product

GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation.

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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