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Class 1 Device Recall Fabius Tiro Date Initiated by Firm March 01, 2018 Create Date May 08, 2018 Recall Status Open, Classified Recall Number Z-1483-2018 Recall Event ID 510(K)Number Product Classification - Product Code Product Fabius Tiro, anesthesia machine, catalog no. download 2015 Buell M2 Cyclone Manual. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
Fabius® Service Manual Table of Contents. Fabius Trolley. download Dassault Falcon 2018 Flight Manual torrent on this page. Strictly follow this instruction manual. Any use of the Fabius Tiro™ requires full understanding and strict observation of these instructions. The unit is only to be used for purposes specified here. download Trane Xl16i Ac Manual torrent more. Recommendations Because of the sophisticated nature of Draeger. Setting up the serial output settings on the Drager Fabius Tiro.
Code Information Serial no: ASKJ-0195 ASKK-0079 ASKF-0226 ASKF-0227 ASKF-0228 ASKF-0229 ASKF-0230 ASKH-0086 ASKH-0071 ASKJ-0177 ASKK-0020 ASKK-0021 ASKH-0053 ASKH-0054 ASKH-0055 ASKH-0056 ASKH-0057 ASKH-0067 ASKH-0068 ASKH-0063 ASKH-0065 ASKH-0064 ASKH-0130 ASKH-0131 ASKJ-0173 ASKH-0031 Recalling Firm/ Manufacturer Draeger Medical, Inc. 3135 Quarry Rd Telford PA Manufacturer Reason for Recall The automatic ventilation may fail if the position detection of the motor is disturbed. download Home Economics Management Teacher Manual torrent. If the ventilator cover is damaged, manual ventilation may also fail. FDA Determined Cause Process control Action On March 1, 2018, the recalling firm notified affected customers via an Urgent Medical Device Recall letter. The recalling firm stated that customers would receive replacement motors for potentially affected devices.