Date Initiated by Firm |
August 05, 2014 |
Date Posted |
August 26, 2014 |
Recall Status1 |
Terminated 3 on February 28, 2017 |
Recall Number |
Z-2554-2014 |
Recall Event ID |
68961 |
Product Classification |
Monitor, bed patient - Product Code KMI
|
Product |
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. |
Code Information |
Lot 0414 |
Recalling Firm/ Manufacturer |
Curbell Medical, Inc. 20 Centre Dr Orchard Park NY 14127-4102
|
For Additional Information Contact |
Michael J. Winter 716-667-3377
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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.
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FDA Determined Cause 2 |
Component design/selection |
Action |
Urgent 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 Commerce |
Domestic: 112 units; Foreign: 211 units |
Distribution |
Nationwide, Canada, Ireland, Italy |
Total Product Life Cycle |
TPLC Device Report
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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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