Events

Recall of Device Recall Precedence SPECT/CT System Upper Patient Pallet

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Phillips Nuclear Medicine.

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
    51274
  • Event Risk Class
    Class 2
  • Event Number
    Z-0897-2011
  • Event Initiated Date
    2009-01-26
  • Event Date Posted
    2011-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79567
  • 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
    Table, powered - Product Code INQ
  • Reason
    A problem has been identified with some upper patient pallets on precedence spect/ct system, which may reduce its load bearing capacity and may result in its cracking. if this were to happens, could pose a risk to patient.
  • Action
    The firm, Philips Healthcare, sent an "Urgent - Field Safety Notice" dated January 26, 2009 to all consignees/customers. The notice described the product, problem and action to be taken by customers and by Philips. The customers were instructed to reference their system's System Operation and System information Manuals regarding loading and unloading of patient; monitoring the patient during a study ,and careful monitoring during unsupported (cantilevered) table translation. Philips has ordered replacement parts and they will have a Philip Healthcare Field Service Engineer contact and visit the customers site within two months to replace the affected upper patient pallet. If you need any further information or support concerning this issue, please contact your local Philips representative at: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: and Oncology or your local Philips Healthcare office.

Device

Device Recall Precedence SPECT/CT System Upper Patient Pallet
  • Model / Serial
    Serial Numbers: 3000037, 3000048
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    International distribution only: Mexico and Saudi Arabia.
  • Product Description
    Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system, || Model Number: 4535 602 50851, Catalog Number: 882350, || Product is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH || Intended use: A single photon nuclear medicine and image from an X-ray computed tomography system.
  • Manufacturer
    Phillips Nuclear Medicine

Manufacturer

Phillips Nuclear Medicine
  • Manufacturer Address
    Phillips Nuclear Medicine, 540 Alder Dr Bldg 4, Milpitas CA 95035-7443
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA