Z-0589-04

All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before...

Name: Z-0589-04 All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before...
Creator: Burton Medical Products Corp
Published: 2004-02-19
License: https://open.fda.gov/license/

Burton Medical Products Corp. / initiated 2004-02-19 / Terminated / root cause: design

FDA source

Burton Medical Products Corp began a recall of All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after... on 2004-02-19. The reason FDA records is "Pivot joint on these ceiling mount lights may fail and lights may fall onto patients". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0589-04
Status: Terminated
Initiated: 2004-02-19
Posted: 2004-07-20
Terminated: 2012-01-25
Recalling firm: Burton Medical Products Corp.
Product: 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.
Product code: KZF Device, Medical Examination, Ac Powered
Reason for recall: Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 17,000 estimated
Distribution: Nationwide.
Product codes and lots: See Product Description

Product code KZF

K851742Class IMedical Examination LightsBurton Medical Products Corp. / cleared 1985-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)