GE Healthcare Flow Sensor Recall: Small Punctures Risk
GE Healthcare recalls flow sensors from August 2020 with potential small punctures in tubes. Affected models include Aespire 7100/11, Aespire 7900, and others. Stop using if you have these parts.
Lower-risk recall
Flow sensors could have damaged tubes in the form of small punctures or cuts.
Contact the company
What happened, in plain English
GE Healthcare is recalling flow sensors made in August 2020 that could cause small punctures or cuts in medical tubes. This risk matters because damaged tubes might lead to complications during medical procedures. Read more at govinfonow.com/recall/64266-ge-healthcare-flow-sensor-recall-small-punctures-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/64266-ge-healthcare-flow-sensor-recall-small-punctures-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0315-2021
Cite this page
“GE Healthcare Flow Sensor Recall: Small Punctures Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64266-ge-healthcare-flow-sensor-recall-small-punctures-risk. Based on FDA recall #Z-0315-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0315-2021%22&limit=1).
Why it’s dangerous
The flow sensors could create small punctures or cuts in medical tubes during use. This might cause leaks or blockages in the tubes, potentially affecting medical procedures.
Who’s affected
Users of GE Healthcare medical devices with the specific flow sensors from August 2020. Patients and healthcare providers using these devices are most at risk.
How to tell if you have this one
Check for flow sensors with an etched manufacturing date of 2020-08 (August 2020). Affected models include Aespire 7100/11, Aespire 7900, Aestiva 7100, and others listed in the recall notice.
- Brand
GE Healthcare- Category
Medical device
All 7 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
U.S. states where product was distributed - 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 Foreign countries impacted - Australia, Canada, Czech Republic, Estonia, France, Germany, India, Indonesia, Israel, Italy, Kuwait, Latvia, Macedonia, Madagascar, Malaysia, Nicaragua, Panama, Qatar, Russia, Singapore, Slovenia, Spain, Thailand, Ukraine, United Kingdom
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0311-2021 | 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.; Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020) | 2 devices |
| Z-0312-2021 | GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: 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.; Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020) | 88 devices |
| Z-0313-2021 | 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.; Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020) | 101 devices |
| Z-0314-2021 | 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.; Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020) | 37 devices |
| Z-0315-2021 | Flow Sensor Service Part, Catalog 2089610-001-S; Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020). This flow sensor is compatible with the following device models: Aespire 7100/11, Aespire 7900, Aespire View, Aestiva 7100, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2, Amingo (OUS), and 9100c NXT (OUS) | 4794 units |
| Z-0316-2021 | Flow Sensor Service Part, Catalog 2087640-001-S; Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020). This flow sensor is compatible with the following device models: Aespire 7100/11, Aespire 7900, Aespire View, Aestiva 7100, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2, Amingo (OUS), and 9100c NXT (OUS) | 388 |
| Z-0317-2021 | Flow Sensor Service Part, Catalog 2096513-001-S; Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020). This flow sensor is compatible with the following device models: Aespire 7100/11, Aespire 7900, Aespire View, Aestiva 7100, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2, Amingo (OUS), and 9100c NXT (OUS) | 2 units |
What to do — step by step
Check Manufacturing Date
Look for an etched manufacturing date on the flow sensor; if it shows 2020-08 (August 2020), it is affected.
Where it went and when
Where it was distributed
Distributed in 36 states, and outside the U.S.
FDA distribution: “U.S. states where product was distributed - 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 Foreign countries impacted - Australia, Canada,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0315-2021 (September 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0315-2021 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.