Events

Recall of Device Recall SmartMonitor 2 PS/PSL

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

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
    77176
  • Event Risk Class
    Class 2
  • Event Number
    Z-2250-2017
  • Event Initiated Date
    2017-05-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155172
  • 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
    Material, embolization, neurovascular, polymerizing or precipitating - Product Code NPE
  • Reason
    Circadiance has determined that it is possible for certain smart monitor 2ps/psl monitors to exhibit intermittent operation of the nurse call feature. the firm has updated the device to increase the "nurse call" feature to ensure monitor alarms are transmitted to compatible nurse call systems.
  • Action
    Circadiance mailed a Medical Device Removal SmartMonitor 2 PS/PSL, dated 04/28/2017, to affected customers to inform them of the issue, the actions to be taken and the actions the firm plans to take to correct the issue. Customers are told to test the functionality of the system prior to each use; and, complete the Business Reply Form. The form can be returned via 412-202-4583 or emailed to james.gianoutsos@circadiance.com. Customers are to contact Circadiance Customer Service at 724-858-2837 to receive an Return Material Authorization number; or, 1-888-825-9640 to repair their unit free of charge, or for questions or support.

Device

Device Recall SmartMonitor 2 PS/PSL
  • Model / Serial
    Unique Device Identifier (UDI) 1030271, 1038140, 1038141, U1030271, and U1038140.  All serial numbers of units with "REF", "MODEL" or standalone part number 1030271, 1038140, 1038141, U1030271 or U1038140 located on the products label are impacted by this notice. Monitors with the above part numbers that have a serial number starting with "CP" are NOT affected by this issue.
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. || Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
  • Manufacturer
    Circadiance LLC

Manufacturer

Circadiance LLC
  • Manufacturer Address
    Circadiance LLC, 1060 Corporate Ln, Export PA 15632-8905
  • Manufacturer Parent Company (2017)
    Circadiance LLC
  • Source
    USFDA