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.
Published September 3, 2014 · Recall initiated: August 5, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Curbell Medical, Inc.
- Distributor
- Nationwide, Canada, Ireland, Italy
- Lot
- Lot 0414
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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