Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith & Nephew Endoscopy, Andover, MA 01810.
FDA Recall Z-0840-2007 · Posted 2007-06-07
Recalling FirmSmith & Nephew, Inc Endoscopy Division
Recall StatusTerminated
Product CodeFFS
Date Initiated2007-04-09
Date Terminated2008-09-02
Product Quantity67 units.
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.
Firm 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).
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
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.