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U.S. Department of Health and Human Services

Class 2 Device Recall Code Alert, Sensatec

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 Class 2 Recall
Code Alert, Sensatec
see related information
Date Posted June 26, 2013
Recall Status1 Terminated on December 03, 2013
Recall Number Z-1597-2013
Recall Event ID 65361
Product Classification Monitor, Bed Patient - Product Code KMI
Product Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.
Code Information all codes
Recalling Firm/
Manufacturer
RF Technologies, Inc.
3125 N 126th St
Brookfield, Wisconsin 53005-3115
Manufacturer Reason
for Recall
RF Technologies, Inc. has initiated a recall involving CA520 Code Alert Integrated Care Management Advanced 4-Way Care Solution . Due to a firmware error, the alarm may not be transmitted to the system server immediately.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Consignees were sent on 5/17/2013 a "Medical Device Recall" letter dated 3 May 2013. The letter described the problem and the product involved in the recall. The letter advised consignees to discontinue use of the device and return to RF Technologies.
Quantity in Commerce 167
Distribution Nationwide Distribution in US including the states of AK, AZ, CA, GA, IA, KY, MT, NE, NJ, ND, and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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