Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific
FDA device recall Z-0873-2007 · posted 2007-06-06 · Terminated
Recall details
- Recalling firm
- Vision Systems Group, A Div of Viking Systems
- Reason for recall
- Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure
- Action taken
- Viking notified 2 distributors and 1 end user by telephone on 3/15/07. Viking representatives performed on site visit to perform inspection and replace units if needed.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 4
- Distribution
- Nationwide to CA and NC
- Date initiated
- 2007-04-05
- Date posted
- 2007-06-06
- Date terminated
- 2007-06-07
- Location
- Westborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUXTEC LIGHT SOURCES (K864385) | Luxtec Corp. | 1987-01-13 |