| 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
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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 |
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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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