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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.

FDA Recall Z-0848-2014 · Posted 2014-01-28

Recall StatusTerminated
Product CodeBTI
Date Initiated2013-12-05
Date Terminated2015-02-05
Product Quantity237 units

Reason for Recall

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

Firm 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 8 am and 6 pm EST. Customers should completed and return the enclosed confirmation form or scan a copy to field [email protected] or fax (973) 807-9290.

Root Cause

Material/Component Contamination

Distribution Pattern

Worldwide Distribution US, Canada and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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