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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 19, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on January 25, 2012
Recall NumberZ-0589-04
Recall Event ID 28229
510(K)NumberK851742 
Product Classification Device, Medical Examination, Ac Powered - Product Code KZF
ProductAll 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.
Code Information See Product Description
FEI Number 2018492
Recalling Firm/
Manufacturer		 Burton Medical Products Corp
21100 Lassen St
Chatsworth CA 91311-4250
For Additional Information ContactSharon Anderson
800-444-9909 Ext. 164
Manufacturer Reason
for Recall		Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.
FDA Determined
Cause 2		Component design/selection
ActionFirm 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 Commerce17,000 estimated
DistributionNationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KZF
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