Events

Recall of Device Recall Philips MultiDiagnost Eleva FD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems Nederlands.

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
    61267
  • Event Risk Class
    Class 2
  • Event Number
    Z-1197-2012
  • Event Initiated Date
    2012-02-24
  • Event Date Posted
    2012-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107691
  • 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, angiographic - Product Code IZI
  • Reason
    Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values.
  • Action
    Philips Healthcare issued Urgent Field Safety Notices dated February 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. No action is necessary by the customer/user. A mandatory Field Safety Correction (FCO) Action will be issued to solve the problem. The FCO will consists of a Software update. For further support customers were instructed to contact their Phillips representative. For questions regarding this recall call 978-687-1501.

Device

Device Recall Philips MultiDiagnost Eleva FD
  • Model / Serial
    Software Version R4.1.x S/N: 3 5 6 8 9 10 12 13 14 15 16 17 18 19 22 23 24 25 26 27 28 29 30 32 33 34 36 37 38 39 40 41 46 47 50 51 52 53 54 55 56 58 60 61 63 64 65 66 67 68 69 70 71 72 73 75 76 77 78 79 80 81 82 83 84 85 88 93 94 95 96 97 98 100 101 103 104 105 106 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 125 126 129 130 131 132 133 134 135 136 137 138 142 143 144 146 147 148 149 151 152 155 157 157 159 160 161 162 167 168 170 174 175 176 177 179 180 181 182 185 186 187 189 190 191 193 194 195 196 197 201 202 204 205 206 207 208 209 210 211 213 213 216 217 219 220 220 221 221 221 222 223 224 225 225 228 233 233 234 235 235 237 237 240 241 241 242 242 244 244 246 246 247 247 249 249 251 251 253 254 254 255 255 257 257 259 261 262 264 265 266 268 269 272 273 277 278
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the following countries: Canada, Australia Austria Belgium Bahrain Czech Republic Denmark Estonia France Finland Germany Hong Kong Israel Italy Latvia Luxemburg Malaysia Mexico Netherlands New Zealand Norway Russian Fed SAUDI ARABIA Serbia Slovakia Solvenia South Africa Spain Switzerland Sweden Syria Thailand Turkey United Kingdom
  • Product Description
    Philips MultiDiagnost Eleva FD, Software R5.1.x || Model: 708034 || Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications.
  • Manufacturer
    Philips Medical Systems Nederlands

Manufacturer

Philips Medical Systems Nederlands
  • Manufacturer Address
    Philips Medical Systems Nederlands, Veenpluis 4-6, Best Netherlands
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA