Class 2 Device Recall Code Alert, Sensatec

• Date Initiated by Firm: May 17, 2013
• Date Posted: June 26, 2013
• Recall Status: 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
• FEI Number: 3002286578
• Recalling Firm/ Manufacturer: RF Technologies, Inc.; 3125 N 126th St; Brookfield WI 53005-3115
• For Additional Information Contact: 800-669-9946
• 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: 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 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.