Events

Recall of Philips Brilliance 64/Ingenuit Family CT Scanners

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
    78863
  • Event Risk Class
    Class 2
  • Event Number
    Z-0518-2018
  • Event Initiated Date
    2017-10-06
  • 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=160757
  • 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
    Numerous issues related to software brilliance ict 4.1.6 software version.
  • Action
    Philips Medical Systems (Cleveland), Inc. sent the Customer Information Letter via certified letters mail with returned receipts. Also, a Field Service Engineer will perform the software update on the system to resolve the issues. Implementation of the software update will be monitored.

Device

Philips Brilliance 64/Ingenuit Family CT Scanners
  • Model / Serial
    Brilliance 64 Code 728231 SN#: 4001 4016 9056 9067 9071 9074 9099 9112 9134 9194 9213 9235 9251 9263 9268 9269 9272 9280 9367 9515 9515 9521 9529 9538 9541 9548 9549 9554 9559 9561 9573 9574 9579 9584 9600 9607 9614 9618 9625 9631 9633 9638 9640 9646 9649 9653 9656 9659 9667 9670 9678 9686 9688 9689 9703 9707 9711 9720 9738 9740 9755 9761 9763 9781 9782 9788 9802 9805 9808 9811 9822 9833 9837 9838 9859 9862 9864 9867 9876 9890 9898 9901 9909 9910 9917 9920 9922 9923 9927 9930 9933 9950 9969 9983 9989 9993 9996 9997 10012 10014 10021 10024 10032 10042 10046 10047 10050 10051 10060 10069 10072 10076 10077 10092 10099 10102 10106 10121 10137 10150 10151 10173 10179 10180 10193 10200 10203 10206 10206 10207 10208 10213 10216 10221 10247 10250 10255 10288 10299 10302 10307 10310 10316 10351 10379 10391 10394 10418 10422 10446 10470 10473 10474 10503 10514 10519 10540 10561 10566 10574 10580 10599 10605 10610 10659 10671 10698 10708 10733 10743 10773 29002 29005 29014 29025 29034 29049 29056 29057 29107 29115 29138 90098 90106 90124 90131 90154 90158 90205 90213 90224 91003 95022 95024 95036 95130 95157 95191 95197 95204 95213 95222 95223 95236 95239 95244 95258 95259 95261 95263 95280 95313 95341 95343 95345 95349 95351 95364 95374 95387 95399 95401 95409 95410 95411 95439 95441 95443 95462 95475 95489 95496 95504 95507 95512 95523 95524 95526 95538 95542 95551 95553 95563 95567 95593 95597 95598 95599 95614 95616 95619 95656 95667 95668 95688 95691 95707 95811 6003368 6003844 6003941 122921 123096 123092 123180 123179 123150 123148 123176 123164 123172 123183 123182 123185 123170 123191 123227 123117 123116
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    26 US Govt accounts
  • Product Description
    Philips Brilliance 64 computed tomography x-ray system
  • 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