Recall Z-0589-04 ยท KZF Device, Medical Examination, Ac Powered
Burton Medical Products Corp
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 SCCS
| Date | Jul 20, 2004 (initiated Feb 19, 2004) |
| Status | Terminated |
| Reason | Pivot joint on these ceiling mount lights may fail and lights may fall onto patients. |
| 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 | 17,000 estimated |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851742 | MEDICAL EXAMINATION LIGHTS Burton Medical Products Corp., May 13, 1985 |