Events

Recall of Device Recall Harmony LC 500

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Steris 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
    54742
  • Event Risk Class
    Class 2
  • Event Number
    Z-1220-2010
  • Event Initiated Date
    2010-02-23
  • Event Date Posted
    2010-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89090
  • 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
    Lamp, surgical - Product Code FTD
  • Reason
    Premature bulb failure.
  • Action
    STERIS issued an "Urgent Field Correction Notice" dated February 23, 2010 via Fed Ex. Consignees were informed of the affected product and were instructed on proper handeling of the device until a STERIS Service Technician contacts the consignee to schedule a service visit. For further information, contact STERIS Field Service Dispatch at 1-800-8828.

Device

Device Recall Harmony LC 500
  • Model / Serial
    Serial Numbers 0436005042-0430207104
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada, Algeria, Australia, Bahrain, Bangladesh, Brazil, Chile, China, Costa Rica, Ecuador, El Salvador, France, Germany, Guam, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, New Zealand, Nigeria, Pakistan, Philippines, Poland, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates, United Kingdom, Italy, Yemen and United Arab Emirates.
  • Product Description
    Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086. || Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    USFDA