Events

Recall of Device Recall Philips Automatic Collimator or Beam Limiting Device

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
    37767
  • Event Risk Class
    Class 2
  • Event Number
    Z-0739-2007
  • Event Initiated Date
    2007-03-15
  • Event Date Posted
    2007-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51483
  • 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
    Collimator - Product Code IZW
  • Reason
    The collimator field-defining light beam does not meet the light field contrast ratio requirement of 4:1. system is non-compliant with performance standard (1020.31 (d)(2)(iii) 21 cfr.
  • Action
    Firm issued letter on 03/20/2007 to consignees advising them that firm representatives will contact consignee to replace collimators at no charge.

Device

Device Recall Philips Automatic Collimator or Beam Limiting Device
  • Model / Serial
    Serial Numbers: 3899, 4334, 4103, 6240, 4560, 4193
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide; Units were distributed to hospitals, radiologists, and health care clinics in IA, LA, ND, PA, and TX, and Washington DC.
  • Product Description
    Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 83501. Product is a Collimator/ Beam Limiting Device and are replacement components for the Bucky Diagnost TH X-ray system.
  • 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