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.
FDA Recall Z-0569-2015 · Posted 2014-12-12
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Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeGCJ
Date Initiated2013-03-05
Date Terminated2014-12-10
Product Quantity1965 cameras
Reason for Recall
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of Australia and Japan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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