Events

Recall of Device Recall Philips Ingenuity Core 728321

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
    80176
  • Event Risk Class
    Class 2
  • Event Number
    Z-2274-2018
  • Event Initiated Date
    2018-03-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164780
  • 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 JAK
  • Reason
    A problem has been detected in the x-ray tube. the affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
  • Action
    Urgent Field Safety Notice letters were sent to customers on 3/28/18. The letters did not request any actions to be conducted by the customers. For Brilliance Big Bore/ Ingenuity CT / Ingenuity Core / Ingenuity Corel 28 Customers: A Philips Field Service Engineer will contact you to schedule the FCO updates at your site. Field Change Order (FCO 72800691 and 72800692) will be released to correct the issue. For Ingenuity TF PET/CT Customers: Field Change Order (FCO 88200520 and 88200511) will be released to correct this issue. A Philips Field Service Engineer will contact you to schedule the FCO updates at your site.

Device

Device Recall Philips Ingenuity Core 728321
  • Model / Serial
    UDI: (01)00884838059498(21)333169, Serial Number: 333169;  UDI: (01)00884838059498(21)310377, Serial Number: 310377;  UDI: (01)00884838059498(21)310375, Serial Number: 310375;  UDI: (01)00884838059498(21)333171, Serial Number: 333171;  UDI: (01)00884838059498(21)333172, Serial Number: 333172
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.
  • Product Description
    Philips Ingenuity Core 728321
  • 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