ClearanceBrief
Recall Z-2271-2013 ยท BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment)

Stryker Endoscopy

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 (024009900

DateSep 24, 2013 (initiated Aug 30, 2013)
StatusTerminated
ReasonWhen 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.
Root causeDevice Design
ActionStryker 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. Customer
Quantity14271 units
DistributionWorldwide 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, Arge
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.