Events

Recall of Device Recall Drager Surgical Lights Sola 500 and Sola 700

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
    53135
  • Event Risk Class
    Class 2
  • Event Number
    Z-2212-2009
  • Event Initiated Date
    2009-08-26
  • Event Date Posted
    2009-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84749
  • 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
    Welded seam may fail.
  • Action
    Draeger Medical, Inc. issued a "Medical Device Recall" letter dated August 2009 via certified mail with return receipt. Consignees were informed on the affected product and that a service representative will be in contact shortly to schedule a replacement. For further information, contact Draeger Medical at 1-800-543-5047, press 1 at the prompt and then 2349.

Device

Device Recall Drager Surgical Lights Sola 500 and Sola 700
  • Model / Serial
    All product with Catalog Number: 4115571.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- IL, KY, and PA.
  • Product Description
    Drager Surgical Lights Sola 500 and Sola 700.
  • 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