Datex-Ohmeda Inc One Ohmeda Recalls
Showing 1-4 of 4 recalls
Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, with a slight color variation to the shade of white being used externally on the machine. There were no design or feature and function modifications when the name change occurred.)
Anesthetic agents could be delivered at concentrations above the concentration set on the S/5 and AS/3 Anesthesia Delivery Units (ADU) having serial numbers within a specified range.
Recall letters dated February 03, 2004 stated that a firm representative would contact the consignee to schedule a visit to replace software and hardware to correct the problem.
Datex-Ohmeda Cardiocap/5 Patient Monitors
Datex-Ohmeda Cardiocap/5 Patient Monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall.
Recall letters dated October 15, 2003 were sent to the consignees on 10/17/03. The letters request that the consignees order service kits to correct the units and use the kits to make the corrections of the devices.
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine
Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.
Recall letters, dated April 26, 2004, stated that a firm representative would contact the consignee to schedule a visit to verify the proper function of each device unit.
Datex-Ohmeda S/5 Anesthesia Delivery Units
Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.
Recall letters dated July 15, 2003 stated that a firm representative would contact the consignees to schedule a visit to replace CPU boards to correct the problem.