Z-2860-2026Class II

Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i...

Name: Z-2860-2026 Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i...
Creator: Maquet Critical Care AB
Published: 2026-06-24
License: https://open.fda.gov/license/

Maquet Critical Care AB / initiated 2026-06-24 / Open, Classified

FDA source

Maquet Critical Care AB began a recall of 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... on 2026-06-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2860-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-24
Posted: 2026-08-03
Recalling firm: Maquet Critical Care AB
Product: 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
Product code: BSZ Gas-Machine, Anesthesia
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 root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 408 US; 11,342 OUS
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2860-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2860-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03

Product code BSZ

K191027Class IIFlow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB / cleared 2020-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)