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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific SpyGlass Camera

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 Class 2 Device Recall Boston Scientific SpyGlass Camerasee related information
Date Initiated by FirmFebruary 07, 2007
Date PostedMarch 31, 2007
Recall Status1 Terminated 3 on November 15, 2007
Recall NumberZ-0699-2007
Recall Event ID 37403
510(K)NumberK971373 
Product Classification Video Camera System - Product Code KOG
ProductBoston 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 ContactDebra Prout
508-683-4433
Manufacturer Reason
for Recall		A teal "bloom"/ glare on the subject image during high light conditions.
FDA Determined
Cause 2		Other
ActionBoston Scientific notified accounts by letter dated 2/1/07 requesting return of product.
Quantity in Commerce12 units
DistributionNationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .
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) Database510(K)s with Product Code = KOG
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