PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 17, 2014 Initiated: March 5, 2013 #Z-0570-2015

Product 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.

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

Details

Recalling Firm
Stryker Endoscopy
Units Affected
1965 cameras
Distribution
Worldwide Distribution - US Nationwide in the states of Australia and Japan
Location
San Jose, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Stryker Endoscopy. Units affected: 1965 cameras.
Why was this product recalled? ▼
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 17, 2014. Severity: Moderate. Recall number: Z-0570-2015.

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