medical Class II Updated 2021-10-06

GE Healthcare, LLC recalls Flow sensors that may be installed in the following GEHC ane

Recalled Product

Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100); (5) S/5 Aespire 7900; (6) Aespire View; (7) Avance; (8) Avance CS2, GTIN 00840682102292; (9) Aisys; (10) Aisys CS2, GTIN 00840682102322; (11) Amingo; (12) 9100 NXT Config, Aelite NXT; (13) Protiva 7100;


Hazard / Issue

The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: The flow sensors built prior to June 2021 that are installed in the devices/anesthesia machines.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →