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U.S. Department of Health and Human Services

Class 2 Device Recall 1488 HD 3Chip Camera; Model Number 1488210105 CMount

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  Class 2 Device Recall 1488 HD 3Chip Camera; Model Number 1488210105 CMount see related information
Date Initiated by Firm March 05, 2013
Date Posted December 12, 2014
Recall Status1 Terminated 3 on December 10, 2014
Recall Number Z-0571-2015
Recall Event ID 69726
510(K)Number K132785  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product 1488 HD 3-Chip Camera;
Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler.

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.
Code Information Model 1488-610-122: 1488 HD 3-Chip Camera Head with Integrated Coupler.  Serial numbers: 12D030204 12D030214 12D030224 12F060834 12F060844 12F060854 12F060874 12F060894 12F060904 12F060914 12F060924 12F060934 12F060954 12F060964 12F060974 12F060984 12F060994 12F061024 12F061054 12F061064 12F061074 12F061084 12F061094 12F061104 12F061114 12F061134 12F061154 12F061164 12F061174 12F061184 12F061194 12F061234 12F061264 12F061274 12F061294 12F061304 12F061314 12F061324 12H001234 12H001244 12H001254 12H001264 12H001274 12H001284 12H001294 12H001304 12H001324 12H038814 12H038824 12H038834 12H038844 12H038854 12H038864 12H038874 12H038894 12H059034 12H059044 12H059054 12H059084 12H059094 12H059104 12H059124 12I004814 12I004834 12I004844 12I004854 12I004864 12I004874 12I004884 12I004894 12I004904 12I004914 12I004954 12I004994 12I005004 12I005014 12I005024 12I005044 12I005054 12I005064 12I005074 12I005084 12I005094 12I005104 12I014974 12I014984 12I014994 12I015004 12I015014 12I015024 12I015034 12I015044 12I015054 12I015064 12I016374 12I016384 12I016394 12I016404 12I016414 12I016424 12I016434 12I016444 12I016454 12I016464 12I016474 12I016484 12I016494 12I016504 12I016514 12I016524 12I016534 12I016544 12I016554 12I016564 12I018674 12I018684 12I018694 12I018704 12I018714 12I018724 12I018734 12I018744 12I018754 12I018764 12I018774 12I018784 12I018794 12I018804 12I018814 12I018824 12I018834 12I018844 12I018854 12I018864 12I018874 12I018884 12I018894 12I018904 12I018914 12I018924 12I018934 12I018944 12I019254 12I019264 12I019274 12I019284 12I019294 12I019304 12I019314 12I019324 12I019334 12I019344 12I033824 12I033874 12I033894 12I033904 12I033914 12I033924 12I033934 12I033944 12I033954 12I033964 12I033974 12I033984 12I033994 12I034004 12I034214 12I034224 12I034234 12I034244 12I034254 12I034264 12I034274 12I034284 12I034304 12I034814 12I034824 12I034834 12I034844 12I034854 12I034864 12I034874 12I034884 12I034894 12I034924 12I034934 12I034944 12I034954 12I034964 12I034974 12I034984 12I034994 12I035214 12I035224 12I035244 12I035254 12I035284 12I035294 12I035304 12J002614 12J002634 12J002664 12J002674 12J002694 12J002714 12J002724 12J002744 12J002804 12J002824 12J002854 12J002864 12J020084 12J020144 12J020154 12J020164 12J020594 12J020614 12J020634 12J020644 12J020654 12J020664 12J063964 12J063994 12J064004 12J064024 12J064034 12J064044 12J064064 12J064074 12J064084 12J064094 12J064104 12J064114 12J064124 12J064144 12J064154 12J064164 12J064174 12J064184 12J064194 12J064204 12J064214 12J064224 12J072934 12J072964 12J072994 12J073014 12J073034 12J073044 12J073054 12J073064 12J073074 12J073084 12K002644 12K002654. 
Recalling Firm/
Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Michael Hilldoerfer
Manufacturer 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
FDA Determined
Cause 2
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 in Commerce 1965 cameras
Distribution Worldwide Distribution - US Nationwide in the states of Australia and Japan
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = Stryker Endoscopy