|
Class 2 Device Recall Code Alert, Sensatec |
|
Date Initiated by Firm |
May 17, 2013 |
Date Posted |
June 26, 2013 |
Recall Status1 |
Terminated 3 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 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 2 |
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.
|
|
|
|