FDA-Device2014-02-05Class II

Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance

Maquet Cardiovascular Us Sales, Llc
Hazard

Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.

Sold states
Worldwide Distribution US, Canada and Japan.
Affected count
237 units
Manufactured in
45 Barbour Pond Drive, Wayne, NJ, United States
Products
Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0848-2014

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