Z-1278-2022Class I

Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire...

Name: Z-1278-2022 Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire...
Creator: Getinge Usa Sales Inc
Published: 2022-05-02
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2022-05-02 / Terminated / root cause: design

FDA source

Getinge Usa Sales Inc began a recall of Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700 on 2022-05-02. FDA classified it as Class I and gives the reason as "Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1278-2022
Classification: Class I
Status: Terminated
Initiated: 2022-05-02
Posted: 2022-06-23
Terminated: 2024-08-06
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Root cause tag: design
FDA root cause: Component design/selection
Action: Maquet Critical Care AB/Getinge initiated a voluntary Medical Device Correction Letter on 5/2/22. . Examine your inventory immediately to determine if you have any of the Flow-c and/or Flow-e anesthesia system(s) with the serial numbers as listed in this notice. . You may continue use of the affected device ensuring that the recommended daily system check out (SCO) and pre-anesthesia checkout procedures are followed as listed in the Operators Manual. . Check for functionality of the suction unit. If you detect a cracked or broken on/off switch before starting a new case, the anesthesia machine should be replaced with a fully functioning anesthesia machine or you should ensure that a temporary alternative suction substitution is available. . Customers with affected system(s) will be contacted by a Getinge Service Representative to schedule on-site correction of your device. 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 8 am and 6 pm (Eastern Time Zone). Whether you have affected product or not, please complete and sign the attached MEDICAL DEVICE Correction - RESPONSE FORM to acknowledge receipt of this notification. Return the completed form to Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to (877) 548-4901. Action by the Getinge: Maquet Critical Care AB/Getinge has identified the cause of the issue. A solution that will correct this issue has been developed and your unit will be corrected at no cost to you by replacing the on/off switch with a new, more durable one.
Quantity in commerce: 17 units US
Distribution: US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia
Product codes and lots: UDI-DI: 07325710009765 Serial Numbers: 4003, 4777, 4783, 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078. (Note: UDI was corrected July 7, 2022)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1278-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1278-2022	Class I	Terminated	Voluntary: Firm initiated	2022-06-29	2022-06-23
Z-1279-2022	Class I	Terminated	Voluntary: Firm initiated	2022-06-29	2022-06-23

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)