Use cautionMedical device recall · FDA · Published August 2, 2021
GE Healthcare Flow Sensors Recalled: Risk of Incorrect Anesthesia Delivery
GE Healthcare recalls flow sensors installed in certain anesthesia machines made before June 2021. These sensors may cause leaks leading to incorrect anesthesia dosing. Affected models include Aestiva MRI, Aestiva 7900, and others.
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.
Take action
Contact the company
📍Recalling firmGE Healthcare, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615
“GE Healthcare Flow Sensors Recalled: Risk of Incorrect Anesthesia Delivery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62101-ge-healthcare-flow-sensors-recalled-risk-of-incorrect-anesthesia-delivery. Based on FDA recall #Z-2596-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2596-2021%22&limit=1).
The FDA announced on Aug. 2, 2021, that GE Healthcare LLC is recalling flow sensors that may be installed in various GEHC anesthesia machines. The agency issued the Class II recall after determining the sensors could cause leaks leading to incorrect tidal volumes.
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks. These leaks may result in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
Context
GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since Oct. 4, 2017. Recent brand recalls include SIGNA Premier MRI Scanners with steel fittings (Feb. 27, 2026), Centricity Universal Viewer inaccurate measurements (July 15, 2022), and SIGNA Premier MRI hearing loss risk (June 24, 2022). Other recent recalls of similar products include Maquet Flow-i Anesthesia Machines inadequate delivery (June 24, 2026), GE Healthcare Carestation Power Board disruption (Nov. 14, 2025), and Draeger Vapor 3000 impure component risk (Nov. 24, 2025).
How to tell if you have this one
Check if your anesthesia machine has a flow sensor installed before June 2021. Affected models include Aestiva MRI, Aestiva 7900, Aestiva 7100, and others listed in the recall notice.
Brand
GE Healthcare
Product
GE Healthcare, LLC recalls Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2)
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Distribution was nationwide, including PR. Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote D'lvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Macedonia, Madagascar, Malaysia, Maldives, Mali, Malta, Mauritius, Mexico, Moldova, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom Uruguay, Venezuela, Vietnam, and Yemen.
Recall number
Product, codes & lots
Z-2595-2021
Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG (gray, autoclavable) 2087640-001-S FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG, SERVICE (gray, autoclavable) 2096513-001-S FLOW SENSOR ASSEMBLY 5697309 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF BCG 5697310 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG; Flow sensors with date of manufacture prior to 2021-06 etched on body of the flow sensor.
Z-2596-2021
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;; The flow sensors built prior to June 2021 that are installed in the devices/anesthesia machines.
Based on the official FDA remedy
What to do — step by step
Check Flow Sensor Date
Verify the installation date of the flow sensor to ensure it was not installed before June 2021.
Contact GE Healthcare
Reach out to GE Healthcare for guidance on whether your specific model requires replacement or repair.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution was nationwide, including PR. Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2596-2021 (August 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2596-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.