BEUDAMED
    FDA Recall Terminated

    Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD version) designed for digital documentation of medical procedures. Manufactured by Stryker Endoscopy, San Jose, CA.

    Recall: Z-0867-2011 · Initiated December 11, 2009

    Recall

    Recall Number
    Z-0867-2011
    Event Number
    54651
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    LMD
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 11, 2009
    Posted
    January 7, 2011
    Terminated
    January 8, 2011
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD version) designed for digital documentation of medical procedures. Manufactured by Stryker Endoscopy, San Jose, CA.

    Reason

    Device will not able to assign the correct time/date stamp for saved filed after December 31, 2009. On Jan 1, 2010, the device system date for all SDC Pro 2 units will re-start from 1 Oct 2001 and begin incrementing from that point onwards. The system date will be incorrect and users will not be able to correct this issue. Problem will not affect how pictures or videos are captured using SDC Pro

    Action

    Stryker Endocoscopy sent an URGENT: Device Correction letter dated December 11, 2009, to the OR Supervisor/Risk Manager and all Stryker Sales Representatives. The letter identified the product, the problem, and the action to be taken by the Sales Representatives. Sales Representatives were to identify affected accounts. Go to customer accounts and install the upgrade for each affected unit. Upon completion of the upgrade, the sales rep was to sign the acknowledgment form indicating that all of their affected accounts received the appropriate software fix and mail to Stryker Endoscopy or fax both sides of the postcard to 408-754-8378 or scan in both sides of the postcard and email to [email protected]. For questions regarding this recall call 408-754-2738 or 408-754-2000.

    Distribution

    Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL IN, IA, KS, KY, LA, MA, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY and the countries of Africa, Australia, Brazil, Cnanda, China, France, Germany, Hong Kong, Iberia, Italy, Japan, Korea, Latin America, Mexico, Netherlands, Poland, Puerto Rico, Scandinavia, Singapore, Switzerland, Thailand, and the UK

    Quantity

    3070 units