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U.S. Department of Health and Human Services

Class 2 Device Recall Flow Anesthesia Machine

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 Class 2 Device Recall Flow Anesthesia Machinesee related information
Date Initiated by FirmJune 24, 2026
Date PostedAugust 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2860-2026
Recall Event ID 99359
510(K)NumberK191027 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductFlow 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 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.
FEI Number 3002808128
Recalling Firm/
Manufacturer		 Maquet Critical Care AB
Rontgenvagen 2
Solna Sweden
For Additional Information ContactMegan Ties
103357300
Manufacturer Reason
for Recall		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 Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce408 US; 11,342 OUS
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BSZ
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