Events

Recall of Device Recall NMT Patient Cable (989803174581)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Electronics North America Corporation.

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
    77166
  • Event Risk Class
    Class 2
  • Event Number
    Z-2175-2017
  • Event Initiated Date
    2017-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155125
  • 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, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    Manufacturing defect may cause localized heating, which may result in localized skin burn.
  • Action
    On May 4, 2017, Philips sent a field safety notice to their consignees. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue: Philips will exchange affected NMT Patient cables at the customer site. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Immediately identify all affected cables, remove them from inventory and hold them for exchange by a Philips Healthcare representative or authorized service provider.

Device

Device Recall NMT Patient Cable (989803174581)
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: AK AZ CA CO FL HI IA IL IN KY MA MD MI MN MO MS NC NE NH NJ NM NV NY OH OR PA TX VA WA WI WV OUS: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Canada Chile China Colombia Costa Rica Denmark Dominican Rep Egypt Finland France Germany Hong Kong Hungary Iceland India Indonesia Ireland Israel Italy Japan Latvia Lebanon Libya Lithuania Luxembourg Malaysia Mexico Mongolia Netherlands New Zealand Norway Oman Pakistan Peru Philippines Poland Portugal Qatar Romania Russia Russian Fed. Saudi Arabia Singapore Slovenia South Africa South Korea Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Ukraine United Kingdom Utd.Arab.Emir.
  • Product Description
    NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA