Reported Dec 14, 2022 · Ongoing

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

Getinge USA Sales Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Getinge Usa Sales Inc · 1 Geoffrey Way · Wayne, NJ · 07470-2035

Is this the product you have?

  • Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Lot codes and dates
  • Flow-c UDI-DI7325710010457 Lot/Serial Numbers
    • 4003
    • 4777
    • 4783
    • 5024
    • 5025
    • 5026
    • 5027
    • 5028
    • 5043
    • 5044
    • 5045
    • 5046
    • 5047
    • 5048
    • 5049
    • 5050
    • 5078
  • Flow-e UDI-DI7325710009765 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
Amount recalled
65 US

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.