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U.S. Department of Health and Human Services

Class 2 Device Recall Endoscope light source.

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 Class 2 Device Recall Endoscope light source.see related information
Date Initiated by FirmApril 09, 2007
Date PostedJune 07, 2007
Recall Status1 Terminated 3 on September 02, 2008
Recall NumberZ-0840-2007
Recall Event ID 37849
510(K)NumberK994084 
Product Classification Endoscope light source - Product Code FFS
ProductSmith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith & Nephew Endoscopy, Andover, MA 01810.
Code Information Serial #s: 420L-1263, 420L-1264, 420L-1265, 420L-1266, 420L-1267, 420L-1268, 420L-1269, 420L-1270, 420L-1271, 420L-1272, 420L-1273, 420L-1275, 420L-1277, 420L-1280, 420L-1281, 420L-1282, 420L-1283, 420L-1284, 420L-1285, 420L-1286, 420L-1287, 420L-1288, 420L-1292, 420L-1293, 420L-1294, 420L-1295, 420L-1296, 420L-1298, 420L-1300, 420L-1301, 420L-1303, 420L-1304, 420L-1305, 420L-1306, 420L-1307, 420L-1308, 420L-1309, 420L-1310, 420L-1311, 420L-1312, 420L-1313, 420L-1314, 420L-1315, 420L-1316, 420L-1317, 420L-1318, 420L-1319, 420L-1320, 420L-1321, 420L-1322, 420L-1344, 420L-1345, 420L-1346, 420L-1347, 420L-1348, 420L-1349, 420L-1351, 420L-1352, 420L-1353, 420L-1354, 420L-1355, 420L-1370, 420L-1403, 420L-1404, 420L-1409, 420L-1422 and 420L-1426.
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc Endoscopy Division
76 S. Meridian Ave
Oklahoma City OK 73107-6512
Manufacturer Reason
for Recall		Several units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. When the unit's power supply draws more that 1A, the fuse will fail causing the light to cease operating. The problem can occur anytime: from the initial turning on (powering up), to anytime during use.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionNotification sent 04/09/07 via FedEx to distribution centers, sales reps and user facilities. Users asked to send light source to Smith & Nephew GMBH Service Center in Germany for repair (contact Ute Dieling at +49 (0) 7462-208-313).
Quantity in Commerce67 units.
DistributionProduct sent to distributors in Argentina, Austria, Chile, Denmark, Dubai, France, Greece, Hong Kong, India, Italy, Japan, Korea, Malaysia, Norway, South Africa, Spain, Sweden and United Kingdom. No US distribution.
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 = FFS
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