Events

Recall of Device Recall Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger Medical, 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
    28101
  • Event Risk Class
    Class 2
  • Event Number
    Z-0358-04
  • Event Initiated Date
    2004-01-09
  • Event Date Posted
    2004-01-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31202
  • 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
    Adjustment screw may break due to material fatigue.
  • Action
    The recalling firm issued a recall letter dated 1/9/03 to their direct accounts. The recall letter informed the accounts of the problem, the potential danger, and that they will be contacted to schedule replacement.

Device

Device Recall Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp
  • Model / Serial
    Catalog numbers 4115571, YG18568, YG19051, and YG19262
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada. The products were shipped to medical facilities in CA, CO, FL, GA, IL, IN, KS, MO, NC, NV, OH, TX, and VA. The product was also shipped to a medical facility in Canada.
  • Product Description
    Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Manufacturer Address
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA