Events

Recall of Philips Verardius

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Healthcare 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
    60064
  • Event Risk Class
    Class 2
  • Event Number
    Z-0118-2012
  • Event Initiated Date
    2011-10-04
  • Event Date Posted
    2011-10-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104361
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • Reason
    Front plate broke in to two pieces causing the c-arm to suspend on the single central bolt.
  • Action
    Philips Healthcare Inc., sent an "URGENT - Field Safety Notice" dated September 30, 2011 to all affected customers. The notice identifies the following: what the problem is and under what circumstances it can occur; the actions that should be taken by the customer/user in order to prevent risks for patients or users and the actions planned by Philips Medical Systems to correct the problem. The notice contains important information for the continued safe and proper use of the equipment and customers were advised to retain a copy with the equipment Instruction for Use. The notice stated that Philips will replace the front plates for systems on the Unit Affected List by the end of June 2012. The notice instructed customers to contact Philips Healthcare representative for further information or support.

Device

Philips Verardius
  • Model / Serial
    Shipped from Nov 2009 to 26 Jul 2011. S/N: 15 22 23 24 26 27 32 42 43 47 48 51 61 62 63 63 66 68 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 105 108 110 114 119 127 128 129 130 131 134 135 136 139 140 141 142 148 152 153 154 155 156 162 163 167 172 176 178 181 181 188 193 195 196 197 198 202 209 210 215 216 219 226 227 238 239 240 242 244 252 254 255 256 257 261 264 269 279 285 291 297 298 299 300 302 303 306 307 308 309 310 311 312 323 324 328 330 341 342 350 371 372 375 380 387 389
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Australia, Austria, Belgium, Bharain, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Norway, Portugal, Russian Fed., Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
  • Product Description
    Philips Verardius Image Intensified X-ray || Catalog Number: 718130 || Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA