Device 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.
Z-2271-2013
Product summary
- Event
- Event 66211
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14271 units
- Official record key
device-enforcement:Z-2271-2013
Official wording
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.
Code information: Model number 0240-095-200, all serial numbers.
Distribution pattern: Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and internationally to Australia, Canada, Chile, China, Argentina, Guam, Taiwan, India, Japan, Korea, Latin America, Philippines, Mexico, New Zealand, Hong Kong, Singapore, and Switzerland.
Derived failure modes
-
Unknown
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.