PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: February 5, 2014 Initiated: December 5, 2013 #Z-0848-2014

Product Description

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.

Reason for Recall

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

Details

Units Affected
237 units
Distribution
Worldwide Distribution US, Canada and Japan.
Location
Wayne, NJ

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 237 units.
Why was this product recalled? ▼
Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2014. Severity: Moderate. Recall number: Z-0848-2014.

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