Z-0422-2023Class II

Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)

Name: Z-0422-2023 Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Creator: Getinge Usa Sales Inc
Published: 2022-11-07
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2022-11-07 / Open, Classified / root cause: design

FDA source

Getinge Usa Sales Inc began a recall of Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900) on 2022-11-07. FDA classified it as Class II and gives the reason as "The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0422-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-07
Posted: 2022-12-07
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power failure. This could require the clinician to use manual emergency ventilation of another ventilator is not available and the backup battery is exhausted.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 11/7/22 the firm notified customers via Urgent Medical Device Correction letters. Customers were instructed to immediately identify whether they had affected Flow-c or Flow-e anesthesia systems on hand. Customers who have affected devices may continue to use the device ensuring that a system checkout procedure is performed per the Operators Manual. The firm will replace the Power backup battery free of charge for customers with affected anesthesia systems. You can also 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: 65 US
Distribution: US Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.
Product codes and lots: Flow-c UDI-DI: 7325710010457 Lot/Serial Numbers 4003 4777 4783 5024 5025 5026 5027 5028 5043 5044 5045 5046 5047 5048 5049 5050 5078 Flow-e UDI-DI: 7325710009765 Lot/Serial Numbers 50012 50013 50014 50015 50016 50017 50030 50031 50033 50034 50035 50036 50037 50038 50039 50040 50041 50042 50043 50046 50047 50048 50051 50052 50053 50054 50055 50056 50057 50058 50059 50060 50061 50062 50069 50070 50071 50072 50073 50074 50084 50085 50086 50087 50088 50089 50090 50091 50092 50093 50094 50096 50097 50108 50109 50110 50111 50132

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0422-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0422-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-07

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)