The Recall Desk

FDA (Devices) recall action 69726

Stryker Endoscopy recalled 3 products on 2014-12-17

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2014-12-17
Critical
0
Units
5,895

Why these products were recalled

In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2014-12-17

    Stryker 1488 HD 3-Chip Camera Recall for Colored Screen Image

    Stryker Endoscopy is recalling 1,965 1488 HD 3-Chip Cameras because a colored screen image may occur in certain operating room environments.

    Product
    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-12-17

    Stryker 1488 HD 3-Chip Inline Camera Recalled for Colored Screen Image

    Stryker Endoscopy is recalling 1,965 HD 3-Chip Inline Cameras because a colored screen image may occur in certain operating room environments.

    Product
    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-12-17

    Stryker Recalls 1488 HD 3-Chip Cameras Due to Colored Screen Image

    Stryker Endoscopy is recalling 1,965 1488 HD 3-Chip Cameras because a colored screen image may occur in certain operating room environments.

    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…
    Category
    Distribution
    0 states