FDA Enforcement
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 or air transportation. Compressor mini is not suitable for use with MRI.
Recall: Z-0848-2014
·
Reported February 5, 2014
Enforcement
- Recall Number
- Z-0848-2014
- Event ID
- 67100
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Maquet Cardiovascular Us Sales, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 5, 2014
- Initiation Date
- December 5, 2013
- Classification Date
- January 28, 2014
- Termination Date
- February 5, 2015
- Address
- 45 Barbour Pond Drive, Wayne, NJ, 07470, United States
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
Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.
Code Info
Part number 6481779
Distribution
Worldwide Distribution US, Canada and Japan.
Quantity
237 units