Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Summary
The FDA issued a Class II for Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Produ by Getinge Usa Sales Inc. Reason: 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 f.
Details
Source
Device Recall
External ID
Z-0422-2023
Action Date
2022-12-14
Status
Ongoing
Category
device
Product Description
Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Lot/Code Info: 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
Quantity Affected: 65 US
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.
Distribution
US Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-07
Company
Wayne, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Getinge Usa Sales Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Getinge Usa Sales Inc have FDA actions?
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0422-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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