Events

Recall of All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: || Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 || Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 || Model 100580 SGL Trolley, Serial No.''s less than TRS962633 || Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 || Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Burton Medical Products 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
    28229
  • Event Risk Class
    Class 2
  • Event Number
    Z-0589-04
  • Event Initiated Date
    2004-02-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31412
  • 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
    Device, Medical Examination, Ac Powered - Product Code KZF
  • Reason
    Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.
  • Action
    Firm will ask for subdistribution information from thier distributors via letter on 1/30/2004. Letters will be sent directly to users. Firm will retrofit all sites with suspect units with new pivot assemblies.

Device

All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufacture...
  • Model / Serial
    See Product Description
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: || Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 || Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 || Model 100580 SGL Trolley, Serial No.''s less than TRS962633 || Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 || Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.
  • Manufacturer
    Burton Medical Products Corp

Manufacturer

Burton Medical Products Corp
  • Manufacturer Address
    Burton Medical Products Corp, 21100 Lassen St, Chatsworth CA 91311-4250
  • Source
    USFDA