Z-2554-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 3, 2014
- Initiation Date
- August 5, 2014
- Termination Date
- February 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 112 units; Foreign: 211 units
Product Description
CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The monitor will sound an alarm.
Reason for Recall
The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However, this modification rendered the monitor's alarm via the nurse call communication port to not function.
Distribution Pattern
Nationwide, Canada, Ireland, Italy
Code Information
Lot 0414