FDA-Device2014-12-17Class II
1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.
Stryker Endoscopy
Hazard
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
Sold states
Worldwide Distribution - US Nationwide in the states of Australia and Japan
Affected count
1965 cameras
Manufactured in
5900 Optical Ct, N/A, San Jose, CA, United States
Products
1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0569-2015Don't want to check this manually?
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