Events

Recall of Device Recall Code Alert, Sensatec

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by RF Technologies, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65361
  • Event Risk Class
    Class 2
  • Event Number
    Z-1597-2013
  • Event Initiated Date
    2013-05-17
  • Event Date Posted
    2013-06-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118623
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, bed patient - Product Code KMI
  • Reason
    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.
  • 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.

Device

Device Recall Code Alert, Sensatec
  • Model / Serial
    all codes
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution in US including the states of AK, AZ, CA, GA, IA, KY, MT, NE, NJ, ND, and WI.
  • Product Description
    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.
  • Manufacturer
    RF Technologies, Inc.

Manufacturer

RF Technologies, Inc.
  • Manufacturer Address
    RF Technologies, Inc., 3125 N 126th St, Brookfield WI 53005-3115
  • Manufacturer Parent Company (2017)
    RF Technologies, Inc.
  • Source
    USFDA