Events

Recall of Device Recall Thoravision I

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems Sales & Service Region No. America.

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
    30569
  • Event Risk Class
    Class 2
  • Event Number
    Z-0369-05
  • Event Initiated Date
    2004-12-01
  • Event Date Posted
    2004-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36133
  • 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, X-Ray, Stationary - Product Code KPR
  • Reason
    X-ray system may fall downward and could possibly hit the patient.
  • Action
    A notification was sent to all customers via certified mail, return receipt requested starting on December 1, 2004. Field Service Engineers will contact the customers to schedule a time for the column exchange starting mid-November and to be completed no later than Mid June 2005.

Device

Device Recall Thoravision I
  • Model / Serial
    The firm uses site numbers instead of serial numbers. The listed site numbers include both Thoravision I and II products.  83956, 13253, 13917, 86223, 25709, 38975, 17579, 13610, 17506, 50321, 100322, 13919, 45032, 44803, 26294, 82617, 76802, 100633, 41354, 26058, 100693, 76806, X0212, 62971, 76374, 59408, 6960, 38715, 10405, 40932, 50319, 50320, 59670, 62972, 86451, X1068, 47101, 47167, 17620, 26214, 76020, 76021, 41437, 38989.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed this product to hospitals and medical centers nationwide.
  • Product Description
    Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811
  • Manufacturer
    Philips Medical Systems Sales & Service Region No. America

Manufacturer

Philips Medical Systems Sales & Service Region No. America
  • Manufacturer Address
    Philips Medical Systems Sales & Service Region No. America, 22100 Bothell Everett Hwy, Bothell WA 98021
  • Source
    USFDA