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Terminated

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.

FDA Recall Z-0196-2009 · Posted 2008-10-24

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeGCJ
Date Initiated2008-09-22
Date Terminated2010-12-21
Product Quantity2265 devices

Reason for Recall

Knob parts stick together, resulting in poor functionality of the knob.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935234STRYKER ENDOSCOPIC VIDEO ACCESSORIESStryker Endoscopy · 1994-03-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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