• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 66211
Product Type Devices
Status Ongoing
Recalling Firm Stryker Endoscopy
City San Jose
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-30
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Model number 0240-095-200, all serial numbers. Class II 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. 14271 units Z-2271-2013
-
-