Z-0804-2016Class I

Flow-i Anesthesia System

Name: Z-0804-2016 Flow-i Anesthesia System
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2015-12-10
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2015-12-10 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire... on 2015-12-10. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0804-2016
Classification: Class I
Status: Terminated
Initiated: 2015-12-10
Posted: 2016-02-22
Terminated: 2016-07-06
Recalling firm: Maquet Cardiovascular Us Sales, LLC
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.
Product code: BSZ Gas-Machine, Anesthesia
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected] 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0804-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0804-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22

Product code BSZ

K133958Class IIFlow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB / cleared 2014-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)