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U.S. Department of Health and Human Services

Class 1 Device Recall Maquet Flowi

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  Class 1 Device Recall Maquet Flowi see related information
Date Initiated by Firm December 10, 2015
Date Posted February 22, 2016
Recall Status1 Terminated 3 on July 06, 2016
Recall Number Z-0804-2016
Recall Event ID 73137
510(K)Number K133958  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product Flow-i Anesthesia System

Product Usage:
The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.
Code Information Model numbers: C20, C30 and C40 (Only Model # C20 for US)  Part numbers: 66 77 200 (US Only), 66 77 300 and 66 77 400  Serial numbers (2743, 2852, 2854, 2855, 2856, 2858
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne NJ 07470
For Additional Information Contact Mr. Josefino Cabinian
973-709-7791
Manufacturer Reason
for Recall		 Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues. Only the Model C20 is affected in the US.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Maquet sent "Urgent Medical Device Field Action Field Correction For Flow-i Anesthesia Systems" letters/Field Correction Response forms dated 12/10/2015 via UPS to affected customers. The notification informed customers of the issue, asked them to distribute the notification to appropriate staff; verify the serial number(s) and informed them they could continue to use the system if they were not experiencing electrical issues. Customers were informed that a Maquet service representative would be contacting them to arrange a time to replace their affected units. Customers were asked to complete and return the enclosed Field Correction Response Form to Maquet at FieldActions@maquet.com or by fax to 973.860.1675. If the customer had any related questions they were instructed to contact Maquet Technical Support at 1.888.627.8383 (option 3; option 1; option 1) Monday through Friday between 8:00 am and 5:00 pm EST.
Quantity in Commerce 7 units within US
Distribution US Nationwide in the states of CA, NY, and OR
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = MAQUET CRITICAL CARE AB
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