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Class 2 Device Recall Boston Scientific SpyGlass Camera |
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| Date Initiated by Firm |
February 07, 2007 |
| Date Posted |
March 31, 2007 |
| Recall Status1 |
Terminated 3 on November 15, 2007 |
| Recall Number |
Z-0699-2007 |
| Recall Event ID |
37403 |
| 510(K)Number |
K971373
|
| Product Classification |
Video Camera System - Product Code KOG
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| Product |
Boston Scientific SpyGlass Camera
Ref Number: 4610 UPN M00546100 |
| Code Information |
Lot Numbers: 061005, 061006, 061007, 061009, 061010, 0161011, 061012, 610130, 61014, 061015, 061016, 061017 |
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
|
| For Additional Information Contact |
Debra Prout
508-683-4433
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Manufacturer Reason
for Recall |
A teal "bloom"/ glare on the subject image during high light conditions.
|
FDA Determined
Cause 2 |
Other |
| Action |
Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product. |
| Quantity in Commerce |
12 units |
| Distribution |
Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA . |
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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.
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| 510(K) Database |
510(K)s with Product Code = KOG and Original Applicant = VISTA MEDICAL TECHNOLOGIES, INC.
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