Events

Recall of Device Recall BrightView, BrightView X, BrightView XCT

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
    69783
  • Event Risk Class
    Class 2
  • Event Number
    Z-0450-2015
  • Event Initiated Date
    2014-11-04
  • Event Date Posted
    2014-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131535
  • 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, tomography, computed, emission - Product Code KPS
  • Reason
    Software issues.
  • Action
    Philips Healthcare sent an URGENT - Field Safety Notice Medical Device Correction letter dated November 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice 88200485 is intended to inform you about: " what the issues are and under what circumstances they can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct these issues. If you need any further information or support concerning these issues, please contact your local Philips representative: For North America contact the Customer Care Solutions Center (1-800-722-9377: follow the prompts). Philips apologizes for any inconveniences caused by this problem.

Device

Device Recall BrightView, BrightView X, BrightView XCT
  • Model / Serial
    BrightView: 11000022, 11000028, 11000050, 1000067, 11000070, 11000073, 1000079, 11000080, 11000084, 11000088, and 11000109.  BrightView X:4000007, 4000034, 4000045, 4000049, 4000050, 4000052, 4000055, 4000057, 4000062, 4000091, 4000110, 4000119, 4000145, 4000178, 4000186, 4000192, 4000203, 4000215, 4000221, 4000234, 4000267, 4000268, 4000273, 4000315, 4000332, 4000335, 4000337, 4000340, 4000343, 4000349, 4000351, 4000359, 4000391, 4000404, 4000436, 4000447, 4000493, 4000497, 4000500, 4000517, 4000595, 4000599, 4000605, 4000609, 4000616, 4000617, 4000622, 4000648, 4000653, and 4000675.  BrightView XCT: 6000018, 6000024, 6000025, 6000029, 6000059, 6000072, 6000074, 6000096, 6000097, 6000106, 6000155, 6000170, 6000179, 6000217, 6000255, 6000259, 6000272, 6000328, 6000342, 6000357, 6000388, 6000405, 6000412, 6340011, and 11000082.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including the states of AR, CA, FL, GA, ID, LA, ME, MI, MN, MO, MS, NJ, NY, OH, OK, PA, and TX. Government Facilities: AR, FL, MN, OH, and OK. and the countries of: Canada, China, Denmark, Germany, Italy, South Korea, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.
  • Product Description
    BrightView product code: 882478 || BrightView X product code: 882480 || BrightView XCT product code: 882482 and 882454
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA