Events

Recall of Device Recall Precedence

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

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
    57589
  • Event Risk Class
    Class 2
  • Event Number
    Z-1549-2011
  • Event Initiated Date
    2010-12-28
  • Event Date Posted
    2011-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96728
  • 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
    Computed Tomography X-Ray System - Product Code JAK
  • Reason
    Philips healthcare nuclear medicine determined that the detector arm assembly could be compromised.
  • Action
    Urgent - Medical Device Correction notifications were sent to all domestic consignees on December 28, 2010 via Federal Express. The letter identified the affected products, the reason for the recall, the hazard involved, and actions to be taken by the customer/user. Customers have been instructed to immediately stop using the system and contact a Philips service representative for an immediate inspection if one of the listed reasons apply. Customers were also instructed to follow the instructions in the system's Instructions For Use to avoid a collision or force on the detector. The firm's service will contact customers to arrange a time for Philips to conduct an inspection and to conduct the appropriate field safety correction. The letter should be placed in customers' Instructions For use. Notices to international consignees will be sent as soon as translation is complete. If customers need further information or support concerning this issue, they should contact their local Philips representative.

Device

Device Recall Precedence
  • Model / Serial
    Catalog number 882350; Model numbers (5/8): 4535-602-50861, 2169-3001A; Serial numbers:  KP05100002 KP05110003 3000006 3000003. Model numbers (3/8): 2169-3000A, 4535-602-50851. Serial numbers: 3000034 3000040 3000044 3000046 3000047 3000049 3000059 3000061 3000063 3000071 3000072 3000074 3000078 30006120020 30007060027 30007060029 KP05040006 KP05080007 KP0510008 KP06040012 KP06060014 KP06100016 3000032 3000054 3000085.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Precedence Imaging System; 16 Slice 5/8, 16 slice 3/8; || Philips Medical Systems || An imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 3860 N 1st St, San Jose CA 95134-1702
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA