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Terminated

Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific Spyglass 300W Light Source (M00546190)

FDA Recall Z-0873-2007 · Posted 2007-06-06

Recalling FirmVision Systems Group, A Div of Viking Systems
Recall StatusTerminated
Product CodeKOG
Date Initiated2007-04-05
Date Terminated2007-06-07
Product Quantity4

Reason for Recall

Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure

Firm Action

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

Distribution Pattern

Nationwide to CA and NC

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K864385LUXTEC LIGHT SOURCESLuxtec Corp. · 1987-01-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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