Reported Oct 2, 2013 · Terminated
Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model…
Stryker Endoscopy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Endoscopy · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
- 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.
- Lot codes and dates
- Model number 0240-095-200, all serial numbers.
- Amount recalled
- 14271 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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