GE Healthcare, LLC 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; Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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;
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
The flow sensors built prior to June 2021 that are installed in the devices/anesthesia machines.
Products Sold
The flow sensors built prior to June 2021 that are installed in the devices/anesthesia machines.
GE Healthcare, LLC is recalling Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN due to The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthes. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recalling firm issued Urgent Medical Device Correction letters on 8/2/2021 via FedEx explaining the safety issue. This letter informs the customer of the issue and provides safety instructions, including requesting the consignee inspect all inventory of flow sensors. GE Healthcare will replace the flow sensors indicated on returned customer response forms, when applicable. The consignee will be responsible for replacing the flow sensor. The letter was sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, Health Care Administrator / Risk Manager
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026