The Recall Desk
ModerateFDA (Devices)·Z-0571-2015·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The defect is a visual display issue (colored screen image) without reported harm, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported or a voluntary precautionary recall.

Plain-English summary

Stryker Endoscopy is recalling 1,965 units of the 1488 HD 3-Chip Camera, Model Number 1488-610-122. This high-definition camera head with an integrated coupler is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery to view endoscopic surgical sites on video monitors and capture images.

The recall was initiated because, in certain operating room environments, a colored screen image occurs with the affected cameras. The source text does not specify the exact nature of the colored image or the specific environmental conditions that trigger the defect.

The affected units were distributed worldwide, including in the United States, Australia, and Japan. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any injuries or illnesses associated with the defect.

The recalled product

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 u
Manufacturer
Stryker Endoscopy
Affected units
1,965

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Stryker Endoscopy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →