Recall Z-0569-2015 ยท GCJ Laparoscope, General & Plastic Surgery
Stryker Endoscopy
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.
| Date | Dec 12, 2014 (initiated Mar 5, 2013) |
| Status | Terminated |
| Reason | In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 1965 cameras |
| Distribution | Worldwide Distribution - US Nationwide in the states of Australia and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132785 | STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY Stryker Endoscopy, Dec 16, 2013 |