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.
FDA Recall Z-0589-04 · Posted 2004-07-20
Recalling FirmBurton Medical Products Corp
Recall StatusTerminated
Product CodeKZF
Date Initiated2004-02-19
Date Terminated2012-01-25
Product Quantity17,000 estimated
Reason for Recall
Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.