Events

Recall of Device Recall Stryker Digital Capture Pro 2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Endoscopy.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54651
  • Event Risk Class
    Class 2
  • Event Number
    Z-0867-2011
  • Event Initiated Date
    2009-12-11
  • Event Date Posted
    2011-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88894
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, digital image communications, radiological - Product Code LMD
  • 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 sdcpro2recall@stryker.com. For questions regarding this recall call 408-754-2738 or 408-754-2000.

Device

Device Recall Stryker Digital Capture Pro 2
  • Model / Serial
    Type: SDC Pro 2; Product Code: LMD, LMB; Model Number: 240-050-800 (CD Version) and 240-050-810 (DVD Version)
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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
  • Product 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.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA