Recall Z-0840-2007 ยท FFS Image, Illumination, Fiberoptic, For Endoscope
Smith & Nephew, Inc Endoscopy Division
Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith & Nephew Endoscopy, Andover, MA 01810.
| Date | Jun 7, 2007 (initiated Apr 9, 2007) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994084 | SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES Smith & Nephew, Inc., Jan 20, 2000 |