Events

Recall of Extended Brilliance Workstation (EBW)

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

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
    57962
  • Event Risk Class
    Class 2
  • Event Number
    Z-1819-2011
  • Event Initiated Date
    2009-10-03
  • Event Date Posted
    2011-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97841
  • 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, tomography, computed - Product Code KPS
  • Reason
    During an fda inspection on 10/1/2010 the firm was notified by fda that their field action they initiated in oct 2009, constituted a recall. the firm determined that the functional analysis feature in the comprehensive cardiac analysis (cca) was displaying incorrect values on the polar fields. the calculated results for the myocardial wall thickening was incorrect in that the numbers displayed f.
  • Action
    Philips sent an URGENT - Field Safety Notice letter dated September 29, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to be aware that the numbers displayed for "Wall Thickening" actually represent a reduction in wall thickness from ES to ED. Philips will be providing a sotware update to resolve the issue. For further information or support customers were instructed to contact their local Philips representative: Customer Care Service Center in the U.S. at 1-800-722-9377, option 5: Diagnostic Imaging option 1: CT or their local Philips representative.

Device

Extended Brilliance Workstation (EBW)
  • Model / Serial
    Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. EBW and NM EBW software versions v2.0.5, v2.0.11. v3.0, v3.0.1, v3.0.2, v3.5, v3.5.2, v3.5.3, v3.5.4, v3.5.35, v4.0.1, v4.0.2, v4.0.3, v4.5.1 and Brilliance Workspace Portal v2.5.1.17, v2.5.1.19.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX , UT, VA, VT, WA, WI, WV & WY and the following countries: ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BELGIUM, BRAZIL, BRUSSEL, CANADA, CHILE, CHINA, COLUMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, EDUADOR, EGYPT, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LATVIA, LEBANON, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB, MIRATES, UNITED KINGDOM, VENEZUELA & YEMEN.
  • Product Description
    Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. || The Extended Brilliance Workplace¿¿ (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The EBW is also provided as a component of PET/CT and SPECT/CT systems, performing the same function as indicated above (also referred to as the NM EBW).
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA