Medical Device Safety and Recalls: FLOW-i Anesthesia Systems - Dislodged Patient Cassette May Stop Patient Ventilation

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: FLOW-i Anesthesia Systems - Dislodged Patient Cassette May Stop Patient Ventilation

A recall has been issued for FLOW-i Anesthesia Systems.  The firm has received several complaints where patient cassettes, which are the center of gas flow in the system, have come loose. The patient cassette locking device may accidentally release the patient cassette from its mount when users perform a change of system. This may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.  The firm has received 10 reports this device has malfunctioned; no injuries or deaths have been reported.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm453492.htm

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