Z-0959-2023Class I

Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part...

Name: Z-0959-2023 Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part...
Creator: Getinge Usa Sales Inc
Published: 2022-12-22
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2022-12-22 / Open, Classified / root cause: software

FDA source

Getinge Usa Sales Inc began a recall of Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400 on 2022-12-22. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0959-2023
Classification: Class I
Status: Open, Classified
Initiated: 2022-12-22
Posted: 2023-01-26
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Design Change
Action: On December 22, 2022, the firm notified affected customers through Urgent Medical Device Correction letters. Customers were instructed to examine their inventory immediately to determine if they have any of the affected serial numbers. If you have an affected system running on software version 4.8.0 through 4.8.3, you may continue use of the device until the software is updated with the following considerations: 1. If during use, the device is switched from Automatic to Manual and it is found that the manual bag is empty the user can activate the Emergency ventilation or turn off/on the device to reset the disabled valves function. 2. Users may also use the resuscitator that is available in the Operating Room. Getinge will update the software to correct the issue free of charge. You can arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9GETUSA / (888) 943 8872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in commerce: 8,016 Total (7,766 OUS; 250 US)
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0959-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0959-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-26
Z-0960-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-26
Z-0961-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-26

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)