Events

Recall of Integris Monitor Arm, model P997-01.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom Co., 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
    26933
  • Event Risk Class
    Class 2
  • Event Number
    Z-1298-03
  • Event Initiated Date
    2003-08-08
  • Event Date Posted
    2003-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29634
  • 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
    The monitor may separate from the monitor arm, allowing the monitor to fall from the arm.
  • Action
    An Urgent Device Correction letter dated 8/8/03 was sent to each hospital account receiving these products. The recall was extended to two additional products via a second letter issued on August 25, 2003. Hospitals were asked to take the units out of service, if possible, until Hill-Rom can inspect/correct them.

Device

Integris Monitor Arm, model P997-01.
  • Model / Serial
    All units distributed prior to June 20, 2003 are affected when used with the P997-11, or the P997A11, accessories allowing for equipment [ satellite racks, CPU's, keyboards, or other equipment] to be installed below the arm.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States, Belgium, Canada, China, Egypt, Hong Kong, Japan, Mexico, Paraguay, Saudi Arabia, Switzerland, Taiwan, Turkey, United Arab Emirates and United Kingdom.
  • Product Description
    Integris Monitor Arm, model P997-01.
  • Manufacturer
    Hill-Rom Co., Inc.

Manufacturer

Hill-Rom Co., Inc.
  • Manufacturer Address
    Hill-Rom Co., Inc., 3 West Pearl St, Batesville IN 47006
  • Source
    USFDA