Events

Recall of Device Recall Philips Healthcare Brilliance 16

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
    74820
  • Event Risk Class
    Class 2
  • Event Number
    Z-2655-2016
  • Event Initiated Date
    2016-07-20
  • 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=148521
  • 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
    After upgrading to 3.6.7 software version via fco72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the ct images. this issue can occur on gated ct helical reconstruction that is not planned at iso-center (0,0). if the region of interest is not visualized in the images, a ct rescan may be performed.
  • Action
    Customers were sent a letter dated July 28, 2016 informing them of the problem, under what circumstances it can occur and the actions that the customer can take to minimize the effect of the problem. The letter also includes the actions planned by Philips to correct the problem. Philips plans on releasing a field change order (FCO) to correct the affected systems. If you need any further information or support concerning this issue, contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1 -800-722-9377).

Device

Device Recall Philips Healthcare Brilliance 16
  • Model / Serial
    728246 -- Brilliance 16  3010 3017 3031 3040 3043 3070 3072 3085 3090 3117 3149 3216 3247 3293 3314 5006 5012 5018 5020 5024 5026 5028 5030 5031 5035 5044 5045 5052 5053 5054 5055 5058 5059 5060 5064 5069 5070 5081 5086 5088 5091 5093 5097 5099 5103 5107 5108 5110 5111 5115 5116 5118 5120 5123 5126 5127 5128 5131 5138 5140 5155 5160 5161 5163 5166 5184 5186 5188 5190 5191 5192 5193 5195 5197 5208 5209 5216 5219 5235 5236 5238A 5270 5272 5279 5282 5285 5287 5294 5295 5315 5316 5350 5354 5357 5360 5368 5394 5433 5434 5443 5453 5457 5480 5487 5501 5502 5505 5519 5523 5526 5554 5572 5573 5576 5609 5615 5633 5647 5653 5683 5723 5758 5762 5764 5771 5811 5897 5929 5937 5956 5974 5995 6021 6022 6031 6033 6048 6053 6072 6220 6229 6243 6280 6283 6298 6309 6321 6360 6375 6405 6426 6441 6465 6474 6484 6503 6511 6517 6519 6523 6549 6559 30049 32287 50011 50053 50087 50180 3123 5674 6555 32366 3465 50181 5135 5237 3179 3411 5009 5048 5077 5412 6154 30011 30110 5101 5181 3324 5405 3050 3441 6387
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA, MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM, NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
  • Product Description
    Brilliance 16, Model number 728246 || Product Usage: || Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
  • 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