Use cautionMedical device recall · FDA · Published December 22, 2022
Getinge Flow-e Anesthesia System Recall: Software Bug Causes Ventilation Failure
Getinge recalls Flow-e Anesthesia System (part 688: 07325710010457) due to software bug causing ventilation failure. Affected units may not build pressure, risking oxygen shortage.
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
Take action
Contact the company
📍Recalling firmGetinge Usa Sales Inc1 Geoffrey Way · Wayne, NJ 07470-2035
“Getinge Flow-e Anesthesia System Recall: Software Bug Causes Ventilation Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59062-getinge-flow-e-anesthesia-system-recall-software-bug-causes-ventilation. Based on FDA recall #Z-0961-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0961-2023%22&limit=1).
Getinge Usa Sales Inc recalled Getinge Flow-e Anesthesia Systems due to a software bug that can prevent pressure buildup and ventilation, according to the FDA. The agency announced the voluntary Class I recall on December 22, 2022.
How to tell if you have it
Brand: Getinge
Product: Getinge Flow-e Anesthesia System
Part No.: 6887900
Serial Numbers: 50012-50197
Software versions: 4.8.0, 4.8.1, 4.8.2, and 4.8.3
The hazard
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
Context
Getinge Usa Sales Inc has 16 other recalls on record since December 9, 2021. Other recent recalls of similar products include Getinge Vaporizer Sevoflurane Recall (January 15, 2025), Getinge MEERA CL Mobile Operating Table Recall (October 3, 2024), and Getinge ALPHAMAXX Mobile Operating Table Charger Recall (May 29, 2024). Other recent recalls of similar products include GE Healthcare Carestation Anesthesia System Power Board Recall (November 14, 2025), Getinge SERVO-U/N Ventilator Sensor Module Recall (June 30, 2026), and Datex-Ohmeda Aisys CS2 Anesthesia System Recall (July 30, 2026).
How to tell if you have this one
Check for part number 6887900 with serial numbers 50012-50197 and software versions 4.8.0 to 4.8.3. The system was sold with specific UDI codes.
Brand
Getinge
Category
Medical device
FDA recall event · 3 products
All 3 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 I
Status
Ongoing
Distribution
US nationwide and Worldwide Distribution: Domestic distribution to AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV. Foreign distribution worldwide.
Recall number
Product, codes & lots
Quantity
Z-0959-2023
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400; Part # UDI 6677200 7325710001349 Serial Numbers 1202-8027 Part # UDI 6677300 7325710001363 Serial Numbers 1058-1201 Part # UDI 6677400 7325710001318 Serial Numbers 2034-8446 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.
8,016 Total (7,766 OUS; 250 US)
Z-0960-2023
Getinge Flow-c Anesthesia System, Part No. 6887700; Part # UDI 6887700 07325710009765 Serial Numbers 4003-5078 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.
8.016 Total (7.766 OUS; 250 US)
Z-0961-2023
Getinge Flow-e Anesthesia System, Part No. 6887900; Part # UDI 6887900 07325710010457 Serial Numbers 50012-50197 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.
8.016 Total (7.766 OUS; 250 US)
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your system's software version is 4.8.0 to 4.8.3 to confirm if it's affected.
Monitor Oxygen Levels
If you have the affected software, ensure oxygen delivery is maintained during use to prevent hypoventilation.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 19 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US nationwide and Worldwide Distribution: Domestic distribution to AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV. Foreign distribution worldwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington, West Virginia.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
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-0961-2023 (December 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0961-2023 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.