Recall Z-2271-2013— Stryker Endoscopy

Class II FDA medical device recall by Stryker Endoscopy, initiated 2013-08-30, terminated 2014-04-30. FDA's recall record names no specific 510(k) clearance for this event. 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 Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.. Reason: When positioning the display located on top of the video cart, it is possible for the user to apply excessive force and push the display up and out of the mounting arm. This can result in the display falling upon the user/patient..

Recalling firm

Stryker Endoscopy

Classification

Class II

Status

Terminated

Initiated

2013-08-30

Terminated

2014-04-30

Firm location

San Jose, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.