Events

Recall of Device Recall Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiolog

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
    67837
  • Event Risk Class
    Class 2
  • Event Number
    Z-1461-2014
  • Event Initiated Date
    2014-03-27
  • Event Date Posted
    2014-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126466
  • 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
    Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. as a result, the table top can become free floating due to the disengaged service latch in the table tops subframe.
  • Action
    A Field Safety Notice was sent to all US consignees via certified mail. Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.

Device

Device Recall Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT...
  • Model / Serial
    Brilliance CT 16: Model Number: 728246; Serial Number: 5314, 6719, 6726, 6727, 6728, 6729, 6730, 6731, 6732, 6734, 6735, 6736, 6737, 6738, 6744, 6746, 6747, 6748, 6749, 6750, 6751, 6752, 6753, 6754, 6756, 6757, 6758, 6759, 6760, 6761, 6762, 6764, 6767, 6768, 6772, and 50213.  Brilliance CT 64: Model Number: 728231; Serial Number: 10805, 10806, 90047, 95880, 95881, 95882, 95885, 95892, 95903, 95907, 95910, 95912, 95913, 95914, 95915, 95918, 95920, 95921, 95922, and 98895. Brilliance CT Big Bore Oncology: Model Number: 728243; Serial Number: 7971, 7977, 7980, 7989, and 7994. Brilliance CT Big Bore Radiology: Model Number: 728244; Serial Number: 7957, 7965, 7979, and 7985. Brilliance iCT: Model Number: 728306; Serial Number: 100477, 100483, 100487, 100489, 100491, 100492, 100494, 100495, 100496, 100500, 100502, 100504, and 100507. Ingenuity CT: Model Number: 728326; Serial Number: 300165 and 333013. Ingenuity Core: Model Number: 728321; Serial Number: 310138, 310142, 310144, 310145, 310149, 310151, 310152, 310153, 310154, 310155, 310158, 310160, 310161, 310162, 310163, 310164, 333013, 333015, and 333017.  Ingenuity Core128: Model Number: 728323; Serial Number: 320113, 320114, 320116, 320117, 320118, 320120, 320121, 320122, 320124, 320125, 320128,320129, 320130, 320134, 320137, 320138, 320139, 320140, 320141, 320142, 320143, 320144,320145, 320146, 320147, 320148, 336009, 336010, 336011, 336012, 336013, 336015, 336016, 336018, and 336023. Ingenuity Flex: Model Number: 728317; Serial Number: 345005
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - USA including the states of CA, FL, IL, IN, KY, MD,SC, and TX.
  • Product Description
    Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.
  • 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