Recall Z-0848-2014 ยท BTI Compressor, Air, Portable
Maquet Cardiovascular Us Sales, Llc
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 ne
| Date | Jan 28, 2014 (initiated Dec 5, 2013) |
| Status | Terminated |
| Reason | Maquet Compressor Mini may deliver compressed air at a temperature higher than specified. |
| Root cause | Material/Component Contamination |
| Action | Maquet sent a product recall urgent-medical device field correction letter/customer fax response via Fed Ex on December 5, 2013, to their customers. Customers are advised of the issues with the device and provided instructions. The correction will include an update with replacement of the affected connector and if needed replacement of the thermoelectric cooler if it damaged. These operations will be performed by an authorized Maquet representative. Any questions can be directed to customer service at 1-888-627-8383 option 2 followed by option 3 Monday through Friday between the hours of |
| Quantity | 237 units |
| Distribution | Worldwide Distribution US, Canada and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023354 | COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E Siemens Elema AB, Sep 5, 2003 |