Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anes

FDA device recall Z-0804-2016 · posted 2016-02-22 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular Us Sales, Llc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

BSZ

Quantity affected

7 units within US

Distribution

US Nationwide in the states of CA, NY, and OR

Date initiated

2015-12-10

Date posted

2016-02-22

Date terminated

2016-07-06

Location

Wayne, NJ

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