Datex-Ohmeda Inc began a recall of Datex-Ohmeda Cardiocap/5 Patient Monitors on . The reason FDA records is "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". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0143-04
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- GE Healthcare
- Product
- Datex-Ohmeda Cardiocap/5 Patient Monitors
- Product code
- MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Reason for recall
- 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.
- FDA root cause
- Other
- Action
- 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.
- Quantity in commerce
- 875 units
- Distribution
- The monitors were shipped to consignees located nationwide in the United States and to foreign consignees located worldwide.
- Product codes and lots
- 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.
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