Events

Recall of STERIS Harmony LL 500/700 Surgical Light

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

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
    53475
  • Event Risk Class
    Class 2
  • Event Number
    Z-0414-2010
  • Event Initiated Date
    2009-09-11
  • Event Date Posted
    2009-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85585
  • 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
    Surgical Lamp - Product Code FTD
  • Reason
    Dr¿ger medical ag & co., kgaa informed steris corporation that they received (4) reported international cases where a welded seam at the joint of the spring-loaded arm of the dr¿ger sola 500/700 surgical light broke as a result of a crack that had slowly developed over time. the steris harmony ll 500/700 surgical light is a private label version of the dr¿ger sola 500/700 surgical light.
  • Action
    The firm sent Urgent Product Correction letters, dated Sept. 11, 2009, to their customers. The letter identified the problem and stated that Drager had supplied STERIS the replacement spring arms and that a STERIS Service Technician would perform the replacement. The letter also stated that the correction would be performed at no charge to the customers. According to the letter, customers would be contacted by their STERIS Service Representative to arrange a convenient time for replacement of potentially affected spring arms. In the meantime, the letter states that customers should use their surgical lights in accordance with the guidelines presented in the Operator's Manual. Questions or concerns regarding the letter should be directed to Barbara Rich at 440-392-7318 or your local STERIS account manager.

Device

STERIS Harmony LL 500/700 Surgical Light
  • Model / Serial
    Part Number: YG18568; Serial Numbers: Year 2002 - 0111 072 XXXXX to 0111 122 XXXXX; Year 2003-0111 013 XXXXX to 0111 123 XXXXX; Year 2004-0111 014 XXXXX to 0111 124 XXXXX; Year 2005-0111 015 XXXXX to 0111 125 XXXXX; and Year 2006-0111 016 XXXXX to 0111 066 XXXXX - (XXXXX means every 5-digit serial number).
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, WA, WI & WY and the country of Canada.
  • Product Description
    STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm. || Intended for local illumination of the operating and examination area of the patient in treatment rooms.
  • Manufacturer
    Steris Corp

Manufacturer

Steris Corp
  • Manufacturer Address
    Steris Corp, 5960 Heisley Rd, Mentor OH 44060
  • Source
    USFDA