Maquet Cardiovascular Us Sales, Llc: 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.

Recall number

Z-2083-2015

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.

Status

Terminated

Initiated

2015-03-02

Posted

2015-07-15

Terminated

2016-04-29

Reason

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.

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

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.

Lot, serial or model codes

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

510(k) numbers

["K133958"]

PMA numbers

not on file

Product code

BSZ

Firm FEI

3008355164

Firm city

Wayne

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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