510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0840-2007

Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured...

Smith & Nephew, Inc. / initiated 2007-04-09 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Smith & Nephew, Inc Endoscopy Division began a recall of Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith & Nephew Endoscopy, Andover, MA 01810 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0840-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Smith & Nephew, Inc.
Product
Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith & Nephew Endoscopy, Andover, MA 01810.
Product code
FFS Image, Illumination, Fiberoptic, For Endoscope
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.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
Notification 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 commerce
67 units.
Distribution
Product 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.
Product codes and lots
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.