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U.S. Department of Health and Human Services

Class 2 Device Recall CareSense Monitor

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 Class 2 Device Recall CareSense Monitorsee related information
Date Initiated by FirmAugust 05, 2014
Date PostedAugust 26, 2014
Recall Status1 Terminated 3 on February 28, 2017
Recall NumberZ-2554-2014
Recall Event ID 68961
Product Classification Monitor, bed patient - Product Code KMI
ProductCURBELL 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.
Code Information Lot 0414
FEI Number 3000210521
Recalling Firm/
Manufacturer		 Curbell Medical, Inc.
20 Centre Dr
Orchard Park NY 14127-4102
For Additional Information ContactMichael J. Winter
716-667-3377
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionUrgent Medical Device Recall Letters (dated 8/01/14) and Response Forms were sent to the consignees via e-mail (w/read receipt) on 8/05/14.
Quantity in CommerceDomestic: 112 units; Foreign: 211 units
DistributionNationwide, Canada, Ireland, Italy
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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