1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definiti

FDA device recall Z-0570-2015 · posted 2014-12-12 · Terminated

Recall details

Recalling firm

Stryker Endoscopy

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

Action taken

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

Status

Terminated

Product code

GCJ

Quantity affected

1965 cameras

Distribution

Worldwide Distribution - US Nationwide in the states of Australia and Japan

Date initiated

2013-03-05

Date posted

2014-12-12

Date terminated

2014-12-10

Location

San Jose, CA

Related 510(k) clearances