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Recall Observatory FDA recall evidence

Device product

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.

Z-0848-2014

December 05, 2013

Class II

Product summary

Firm
Maquet Cardiovascular Us Sales, Llc
Event
Event 67100
Status
Terminated
Classification
Class II
Quantity
237 units
Official record key
device-enforcement:Z-0848-2014

Official wording

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

Code information: Part number 6481779

Distribution pattern: Worldwide Distribution US, Canada and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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