Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith &
FDA device recall Z-0840-2007 · posted 2007-06-07 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc Endoscopy Division
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FFS
- Quantity affected
- 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 U
- Date initiated
- 2007-04-09
- Date posted
- 2007-06-07
- Date terminated
- 2008-09-02
- Location
- Oklahoma City, OK
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES (K994084) | Smith & Nephew, Inc. | 2000-01-20 |