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U.S. Department of Health and Human Services

Class 2 Device Recall Flowc, Flowe

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 Class 2 Device Recall Flowc, Flowesee related information
Date Initiated by FirmNovember 07, 2022
Date PostedDecember 07, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0422-2023
Recall Event ID 91088
510(K)NumberK191027 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductFlow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Code Information 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
Recalling Firm/
Manufacturer		 Getinge Usa Sales Inc
1 Geoffrey Way
Wayne NJ 07470-2035
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionOn 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 Commerce65 US
DistributionUS Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BSZ
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