Events

Recall of Device Recall Guardian Services

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

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
    53133
  • Event Risk Class
    Class 2
  • Event Number
    Z-0168-2010
  • Event Initiated Date
    2009-07-31
  • Event Date Posted
    2009-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84747
  • 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
    Digital Image Storage Radiological Device - Product Code LMB
  • Reason
    Product serving as data backup protection does not contain 100% data backup for all netpractice customers on a daily basis.
  • Action
    Firm notified consignees by an Urgent: Device Correction letter, dated July 31, 2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also provides Stryker's recommendations for reducing risk to patients. Technical instructions on the backup storage for the NetPractice are included with the letter. Stryker will not bill customers for the Guardian Service until the problem is remediated and Stryker notifies customers. If there are questions, customers should contact Stryker at 972-410-7100.

Device

Device Recall Guardian Services
  • Model / Serial
    All accounts that have NetPractice and are signed up for Guardian Services backup.
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice). || The intended us of Guardian is to act as a medical data backup and disaster recovery plan.
  • Manufacturer
    Stryker Imaging

Manufacturer

Stryker Imaging
  • Manufacturer Address
    Stryker Imaging, 1410 Lakeside Pkwy Ste 600, Flower Mound TX 75028-4027
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA