The Recall Desk
HighFDA (Devices)·Z-2271-2013·Announced 2013-10-02

Stryker Vision Mounting Arm Recalled Due to Display Detachment Risk

Stryker Endoscopy is recalling 14,271 Vision Mounting Arms because excessive force can cause the display to detach and fall on users or patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where the display can fall on a user or patient, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria.

Plain-English summary

Stryker Endoscopy is recalling 14,271 units of the Stryker Vision Mounting Arm, model number 0240-095-200. This medical device is used in surgical operating rooms to hold and position LCD monitors for Stryker Endoscopy products. The recall covers all serial numbers of this model.

The recall was initiated because it is possible for a user to apply excessive force when positioning the display on the video cart, which can push the display up and out of the mounting arm. This failure mode can result in the display falling upon the user or patient. The product was distributed worldwide, including the United States and various international locations.

Healthcare facilities should stop using the affected mounting arms and contact Stryker Endoscopy for instructions on how to proceed with the recall.

The recalled product

Product
Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker
Manufacturer
Stryker Endoscopy
Affected units
14,271

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model number 0240-095-200
  • all serial numbers.

Distribution