1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, 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.
Recall
- Recall Number
- Z-0570-2015
- Event Number
- 69726
- Firm
- Stryker Endoscopy
- FEI Number
- 2936485
- Product Code
- GCJ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- March 5, 2013
- Posted
- December 12, 2014
- Terminated
- December 10, 2014
- Address
- 5900 Optical Ct, San Jose, CA, 95138-1400
Description
1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, 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.
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
Stryker sent Device Recall letters to Risk Managers of affected sites on March 1, 2013. The issue was described and the fact that there have been no reports of patient harm. If user observe the colored screen prior to placement of the camera, unplug and reconnect the camera head into the console and/or power cycle the console to correct the issue. Local Stryker Representatives will coordinate the removal and replacement of the camera in the next several months. Questions may be directed to Stryker at 408-754-2517.
Worldwide Distribution - US Nationwide in the states of Australia and Japan
1965 cameras