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.
This recall has been terminated (originally issued September 24, 2013).
- Company
- Stryker Endoscopy
- Recall Initiated
- August 30, 2013
- Posted
- September 24, 2013
- Terminated
- April 30, 2014
- Recall Number
- Z-2271-2013
- Quantity
- 14271 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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.
Lot / Code Info
Model number 0240-095-200, all serial numbers.
Root Cause
Device Design
Action Taken
Stryker Endiscopy sent an Urgent Device Correction letter dated August 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inform individuals within their organization who needed to be aware of this Medical Device Field Correction, contact Stericycle at 1-877-546-0482 or email stryker4645@stericycle.com to schedule a time for Stericycle to perform the correction, or perform the correction themselves by requesting the materials and following the correction instructions included. Customers were also instructed to report all adverse events or product quality problems to Stryker Endoscopy at 1-800-624-4422, press 3 for Customer Service. --UPDATE-- On September 17, 2013, the recall was expanded to include additional customers who may have received the screw and washer included with the design change update. Notification was sent to these consignees on September 17, 2013. .