Events

Recall of Device Recall EasyDiagnost DSI

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems North America Co. Phillips.

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
    46217
  • Event Risk Class
    Class 2
  • Event Number
    Z-2406-2010
  • Event Initiated Date
    2008-01-04
  • Event Date Posted
    2010-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67011
  • 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
    Radiographic Tilting Table - Product Code IXR
  • Reason
    Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path.
  • Action
    On 1/4/08, the firm issued the URGENT PRODUCT CORRECTION letter dated 1/3/08 to their consignees via certified mail, return receipt requested. The letter informs consignees the issue of the safety switch and counter weight steel band on the Diagnost 55/66/76Plus, Easy Diagnost, and Easy Diagnost Eleva X-ray systems. However, the Easy Diagnost Eleva X-ray system was distributed and applied only to foreign consignees outside US. If the consignees hear the primary steel band clicking/rattling noise while tilting the table to 90 degrees table or positioning the serial changer, the consignees are instructed to tilt the table base towards the 0 degree tilting position and do not use the tilting drive movement until the mandatory action by a Philips service representative has been performed. The Field Change Order (FCO) would be implemented on 01/23/08 and expected to be completed by July 2008. The firm's representatives will visit sites and will inspect all systems where the switch has been replaced or adjusted for proper operation of the safety sensor and switch. Two steel bands will be inspected and replaced if any abnormity is noted. In the mean time, consignees should contact Philips Call Center at 800-722-9377, #5, #2 and reference the FCO 70600029 with any questions.

Device

Device Recall EasyDiagnost DSI
  • Model / Serial
    Devices are identified as SITE numbers:  62663, 76379, 38988, 38689, 41468, 82571,102466, 103158, and 104104.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Easy Diagnost DSI is a Easy Diagnost Digital Spot Imaging system. It has a capability to create digital images from an analog system. || Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA