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Flow Anesthesia Machine recallZ-2860-2026 · Maquet Critical Care AB · initiated Jun 24, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Critical Care AB or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.

FDA root cause category: Under Investigation by firm

What the company is doing

On June 24, 2026, the firm began issuing "Urgent Medical Device Correction" letters via FedEx to customers at the Risk Manager level. Customers were informed that according to the Instructions for Use, this indication signifies that concentration levels are below detectable limits, serving as confirmation that no agent is present: **/gas analyzer has no information to display Customers were given recommended precautions to identify and mitigate the issue, such as confirming that the anesthetic agent is being delivered after activating the vaporizer, and continuously monitoring end-tidal anesthetic agent concentration and patient vital signs to ensure adequate anesthesia is maintained. If delivery is not confirmed, end case and start up again. The firm has developed a software update, version 4.8.7, which will improve stability during case start-up, thereby reducing the risk of no anesthetic agent delivery events. Customers are instructed to identify all affected product in their inventory and notify any individuals within their organization or where the affected devices have been transferred. Customers should contact their local Getinge representative to assist with downloading the updated software.

Recall details

Recall number
Z-2860-2026
Status
Open, Classified
Initiated by the company
Jun 24, 2026
Posted by the FDA
Aug 3, 2026
Recalling firm
Maquet Critical Care AB
Quantity
408 US; 11,342 OUS
Product code
BSZ
FDA submissions
K191027
Distribution
Worldwide - US Nationwide distribution to the states of AL, AR, CA, CO, DC, DE, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, SC, TX, VA, WA, WV.

Product description

Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900

Code information (models, lots, serial numbers)

Flow-i C20 6677200 / UDI-DI 07325710001349 Flow-i C30 6677300 / UDI-DI 07325710001363 Flow-i C40 6677400 / UDI-DI 07325710001318 Flow-i C20 6888520 / UDI-DI 07325710010617 Flow-i C30 6888530 / UDI-DI 07325710010624 Flow-i C40 6888540 / UDI-DI 07325710010631 Flow-c 6887700 / UDI-DI 07325710009765 Flow-e 6887900 / UDI-DI 07325710010457 Software versions 4.8, 4.10, and 4.11.

Devices named in this recall

8 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K191027 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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