Events

Recall of Device Recall General XRay System types with Digital Spot Imaging (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
    48602
  • Event Risk Class
    Class 2
  • Event Number
    Z-2160-2008
  • Event Initiated Date
    2008-05-23
  • Event Date Posted
    2008-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71705
  • 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
    X-Ray - Product Code IZJ
  • Reason
    X-ray images may be stored in the wrong patient file or corrupted, images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted).
  • Action
    On 5/20/08 the firm issued an URGENT - DEVICE CORRECTION letter to the consignees advising of the problem, requesting consignees to check the stored or printed images to ensure that it represents the data and images captured from the examination. The firm will issue a Field Change Order to their service representatives providing new software, when software is available. This should be issued by the end of June.

Device

Device Recall General XRay System types with Digital Spot Imaging (DSI)
  • Model / Serial
    Software version: rel 6 serial numbers: 8, 18, 31, 40, 41, 45, 51, 52, 62, 63, 67, 71, 78, 79, 83, 84, 87, 88, 99, 100, 102, 104, 105, 106, 112, 116, 117, 118, 119, 127, 131, 132, 134, 136, 143, 146, 149, 153, 157, 163, and 164
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    General X-Ray System types with Digital Spot Imaging (DSI) software
  • 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