Events

Recall of Stryker Endoscopy SDC HD and SCD HDi

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
    54683
  • Event Risk Class
    Class 2
  • Event Number
    Z-1590-2010
  • Event Initiated Date
    2009-10-23
  • Event Date Posted
    2010-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89008
  • 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
    Device, digital image storage, radiological - Product Code LMB
  • Reason
    Video device is not able to assign the correct time/date stamp.
  • Action
    Stryker Endoscopy has notified the 2865 domestic consignees affected by the device correction. The notification was mailed to affected consignees and their corresponding sales representatives. It included two mailings of the Urgent: Device Correction notice, SDC HD 3.0z correction software, and a SDC HD upgrade dongle. 100% of consignees have been contacted and notified of the device correction needed. The effectiveness of the correction has been tracked via acknowledgement cards mailed, faxed, or emailed. The local Stryker Sales Representative will install a software upgrade to fix this issue. Additional questions should be directed to the firm's Customer Service at (800)624-4422 or (408)754-2039.

Device

Stryker Endoscopy SDC HD and SCD HDi
  • Model / Serial
    Product Name: SDC HD units and SDC HDi units Model Nuumbers: 240-050-888 and 240-050-888i Code: All SDC HD and SDC HDi units
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US government facilities and other US domestic consignees(nationwide), and to foreign countries
  • Product Description
    An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to capture still images and to record video during the surgical procedures in various file formats. Images can be transferred to external media.
  • 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