| Date Initiated by Firm | April 05, 2007 |
|---|
| Date Posted | June 06, 2007 |
|---|
| Recall Status1 |
Terminated 3 on June 07, 2007 |
| Recall Number | Z-0873-2007 |
|---|
| Recall Event ID |
37793 |
| 510(K)Number | K864385 |
|---|
| Product Classification |
Light Source for Endoscopes - Product Code KOG
|
| Product | 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) |
|---|
| Code Information |
Units manufactured from 1/23/07 through 3/14/07 with serial numbers: 120906, 016707, 016907, 017007 |
Recalling Firm/
Manufacturer |
Vision Systems Group, A Div of Viking Systems
134 Flanders Rd
Westborough MA 01581-1023
|
Manufacturer Reason
for Recall | Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure |
|---|
FDA Determined
Cause 2 | Nonconforming Material/Component |
|---|
| 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. |
|---|
| Quantity in Commerce | 4 |
|---|
| Distribution | Nationwide to CA and NC |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = KOG
|
|---|
