Reported Sep 3, 2014 · Terminated
CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed…
Curbell Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Curbell Medical, Inc. · 20 Centre Dr · Orchard Park, NY · 14127-4102
Is this the product you have?
- CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; ---
- COMMON/USUAL NAMEBed Patient Monitor
- CLASSIFICATION NAMEBed 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
- Lot codes and dates
- Lot 0414
- Amount recalled
- Domestic: 112 units; Foreign: 211 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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