FDA Device

Datex-Ohmeda Cardiocap/5 Patient Monitors

Hazard

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.

What You Should Do

Remedy

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.

Products

Datex-Ohmeda Cardiocap/5 Patient Monitors
Brand
Datex-Ohmeda Inc One Ohmeda
UPC
The monitors in the serial number range FBWF00725 through FBWF03055 and FBWG00001 through FBWG02015 could be affected by the problem if they are mounted on the optional mounting stands for the product. The consignees notified of the field correction had purchased both the monitors and the stands.

Units Affected

875 units