Events

Recall of Device Recall Philips Health Ingenuity Flex

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
    79666
  • Event Risk Class
    Class 2
  • Event Number
    Z-1404-2018
  • Event Initiated Date
    2018-02-08
  • 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=162941
  • 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
    Closing the emergency stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
  • Action
    The recalling firm notified customers of the recall on February 8, 2018, via Urgent Field Safety Notice. The notice advised customers of the issue and affected products and lot numbers. Customers were advised that once the E-stop has been closed, the operator/technologist must initate a brief horizontal motion (in or out) using any of the operator control panels, CT-Box or tape/foot switches. This action will ensure the couch carbon top (upper pallet) is in a controlled state. Customers were informed that a Field Service Engineer would contact them to schedule site updates to correct the issue. Customers who need further information or support were advised to contact their local Philips representative. Additionally, they may contact the Customer Care Solutions Center (1-800-722-9377.

Device

Device Recall Philips Health Ingenuity Flex
  • Model / Serial
    Serial No. : 345247 345268 345206 345248 345208 345244 345253 345257 345279 345054 345059 345067 345066 345069 345068 345085 345100 345099 345048 345047 345049 345050 345052 345051 345053 345055 345056 345057 345058 345076 345062 345060 345061 345063 345065 345064 345074 345070 345072 345071 345073 345077 345075 345078 345079 345080 345081 345082 345116 345083 345084 345086 345087 345088 345091 345092 345094 345093 345095 345096 345098 345097 345102 345101 345103 345105 345106 345104 345107 345118 345111 345108 345109 345112 345113 345114 345115 345118 345117 345119 345120 345275 345202 345210 345249 345252 345263 345266 345246 345201 345226 345211 345207 345211 345214 345215 345216 345217 345219 345224 345223 345225 345227 345230 345229 345234 345236 345242 345240 345243 345245 345251 345256 345232 345258 345261 345265 345274 345273 345272 345278 345220 345255 345205 345209 345213 345212 345221 345222 345233 345235 345239 345238 345259 345260 345231 345241 345204 345276 345277 345269 345203 345228 345250 345262 345267 345270 345228 345237 345271 345202
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
  • Product Description
    Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system || 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
  • 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