Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific SpyGlass Visualization Probe

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Boston Scientific SpyGlass Visualization Probe see related information
Date Initiated by Firm February 07, 2007
Date Posted March 31, 2007
Recall Status1 Terminated 3 on November 15, 2007
Recall Number Z-0696-2007
Recall Event ID 37403
510(K)Number K052194  
Product Classification Mini-Endoscope - Product Code KOG
Product Boston Scientific SpyGlass Visualization Probe
Reference Number: 4603 UPN M00546030
Code Information Lot number: 527301, 527302, 533202, 625401, 628902, 630001, 633201, 635501, 702901
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Debra Prout
508-683-4433
Manufacturer Reason
for Recall		 SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe
FDA Determined
Cause 2		 Other
Action Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.
Quantity in Commerce 115 units
Distribution Nationwide 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) Database 510(K)s with Product Code = KOG and Original Applicant = BOSTON SCIENTIFIC CORP.
-
-