Recall Z-0848-2014— Maquet Cardiovascular Us Sales, Llc
Class II · Terminated
Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2013-12-05, terminated 2015-02-05. It names one FDA 510(k) clearance: K023354. 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.. Reason: Maquet Compressor Mini may deliver compressed air at a temperature higher than specified..
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-05
- Terminated
- 2015-02-05
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.