Z-2083-2015Class II

The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia...

Name: Z-2083-2015 The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2015-03-02
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2015-03-02 / Terminated

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation... on 2015-03-02. FDA classified it as Class II and gives the reason as "Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a decrease or loss of...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2083-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-02
Posted: 2015-07-15
Terminated: 2016-04-29
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.The system is intended for use in a wide range of population: from neonatal to adult patients. The system is intended for use in hospital environments, except for the MRI environment, by healthcare professionals trained in inhalation anesthesia administration. Auxiliary O2 and Suction Module: Is an option available for the FLOW-i Anesthesia System. The module contains two main parts: Flowmeter unit: The intended use of the flowmeter is to provide oxygen for patient therapy. Suction unit: The intended use is to extract body fluids from the stomach and airways.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a decrease or loss of suctioning capability of the modules.
FDA root cause: Under Investigation by firm
Action: Maquet sent an Urgent Medical Device Field Action Removal and Replacement Form/Device Removal Response Form dated March 2, 2015 to their affected customers via FedEx. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed read through the letter and inform all members of their staff who may use the affected device. Fill out the attached Device Removal Response Form with requested information, sign and date and fax/email the Response Form using the fax/email information provided. Customers with questions were instructed to contact their Maquet Service Representative or Maquet Technical Support at 1-888-627-8383 (press option 3, followed by option 1 and then optionn 1 again.
Quantity in commerce: 104 units
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, India, Israel, Japan, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand and United Arab Emirates.
Product codes and lots: Device Part number: 66 79 847 Serial Numbers: 4, 14-24, 26-29, 31, 37, 40, 56, 138, 199, 205, 367, 369-372, 391, 394-395, 416, 466-491, 517, 519, 525, 567-568, 570, 582-583, 606, 613, 619, 627, 629-631, 633, 635-641, and 643-665

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2083-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2083-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-15

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)