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U.S. Department of Health and Human Services

Class 3 Device Recall Vision Elect HDTV Surgical Viewing Monitor

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 Class 3 Recall
Vision Elect HDTV Surgical Viewing Monitor
see related information
Date Posted October 24, 2008
Recall Status1 Open
Recall Number Z-0196-2009
Recall Event ID 49549
Premarket Notification
510(K) Number
K935234 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product 26" Vision Elect HDTV Surgical Viewing Monitor, model number 0240030960, Manufactured by Stryker Endoscopy San Jose Intended to be used as a visualization device for events occurring in the sterile field for endoscopic surgical procedures.
Code Information PER Number(s): 98131, 99085,101141,105591,101235,101212, 109617, 110104, 110852,110974,111006,111048,111081,111105, 111181, 111199, 111202, 111303, 111492, 111562, 111595, 111868, 111912, and 111935
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose, California 95138
Manufacturer Reason
for Recall
Knob parts stick together, resulting in poor functionality of the knob.
FDA Determined
Cause 2
DESIGN: Device Design
Action Urgent: Device Correction letters dated 9/22/2008 were sent to Sales representatives and all accounts. Sales reps were also notified via email. Each Sales Rep was provided rework instructions, a list of affected accounts and serial numbers, and new knobs to install on affected units. Customers were asked to inspect their inventory for the part number, they were informed that their sales rep would be responsible for replacing the rotary knobs on all affected units, and that they should contact their sales rep to schedule the knob replacement.
Quantity in Commerce 2265 devices
Distribution Worldwide Distribution --- USA including states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming, and countries of Australia, Canada, China, England, France, Germany, Greece, Iberia, India, Israel, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Scandinavia, Singapore, South Africa, Switzerland, and Taiwan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = STRYKER ENDOSCOPY
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