CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report

Flow-i C40 Anesthesia System recalled by Getinge Usa Sales

Getinge Usa Sales is recalling Flow-i C40 Anesthesia System, distributed nationwide in the US. The recall was initiated on 11 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 07325710001318, serial numbers (US): 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, 8446.

Quantity recalled16 (US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0989-2024
FDA event ID: 93736
Recalling firm: Getinge Usa Sales, Wayne, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 11 Dec 2023
FDA classified: 6 Feb 2024
Reported: 14 Feb 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

11 Dec 2023	Recall initiated by company
6 Feb 2024	Classified by FDA	+57 days
14 Feb 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Flow-i C40 Anesthesia System, model 6677400

Where it was distributed

Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA & WV.

Nationwide Alabama Arkansas Arizona California Colorado District of Columbia Florida Georgia Indiana Massachusetts Michigan Missouri New York Ohio Oregon Pennsylvania Texas Virginia Washington West Virginia

Questions about this recall

Is Flow-i C40 Anesthesia System recalled?

Yes. Getinge Usa Sales recalled Flow-i C40 Anesthesia System on 11 Dec 2023. The recall is Class II and its status is Ongoing. Recall number Z-0989-2024.

Why was it recalled?

Which lots are affected?

UDI-DI: 07325710001318, serial numbers (US): 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, 8446.

Where was it sold?

Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA & WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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