Events

Recall of Philips

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

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
    68226
  • Event Risk Class
    Class 2
  • Event Number
    Z-1789-2014
  • Event Initiated Date
    2014-04-29
  • Event Date Posted
    2014-06-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127178
  • 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, apnea, home use - Product Code NPF
  • Reason
    The battery pack wire harness is improperly assembled rendering the device inoperable. the wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. the presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed.
  • Action
    Philips sent an Urgent Medical Device Correction letter dated April 29, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Customer Information is intended to inform you about: 1.what the problem is and under what circumstances it can occur 2.the actions that you as a customer can take to minimize the effect of the problem 3.the actions planned by Philips to correct the problem. If you need any further information or support concerning this issue, please contact your local Philips representative: For further questions please call (412) 380-8881. Philips apologizes for any inconveniences caused by this problem.

Device

Philips
  • Model / Serial
    989805603611 / 1014557, 989805603631 / 1014559, 989805604511 / 1028969, 989805604521 / 1028970, 989805604531 / 1028971, 989805604631 / 1030271, 989805605051 / 1038140, 989805605061 / 1038141, 989805608801 / U1014557, 989805608811 / U1014559, 989805608831 / U1028969, 989805608841 / U1028970, 989805608851 / U1038140, 989805604231 / 1023384
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including the states of MI, WI, SC, FL, TX, KS, MA, AZ, UT, WV, IN, MN, NV and VA., and the countries of Australia, Belgium and Canada.
  • Product Description
    Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
  • Manufacturer
    Childrens Medical Ventures

Manufacturer

Childrens Medical Ventures
  • Manufacturer Address
    Childrens Medical Ventures, 191 Wyngate Dr, Monroeville PA 15146-3045
  • Source
    USFDA