ClearanceBrief
Recall Z-0143-04 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Datex-Ohmeda Inc

Datex-Ohmeda Cardiocap/5 Patient Monitors

DateJul 20, 2004 (initiated Oct 17, 2003)
StatusTerminated
ReasonDatex-Ohmeda Cardiocap/5 Patient Monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall.
Root causeOther
ActionRecall 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.
Quantity875 units
DistributionThe monitors were shipped to consignees located nationwide in the United States and to foreign consignees located worldwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K012837MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
Datex-Ohmeda, Sep 14, 2001
K992323DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
Datex-Ohmeda, Inc., Nov 1, 1999