Reported Aug 15, 2012 · Terminated

Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System

Philips Healthcare Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Healthcare Inc. · 3000 Minuteman Road · Andover, MA · 01810

Is this the product you have?

  • Philips MultiDiagnost Eleva
  • with Flat Detector (MD Eleva FD)Model708034
  • Product UsagePhilips X-ray System
Lot codes and dates
  • US Serial Numbers96
    • 104
    • 111
    • 120
    • 170
    • 222
    • 223
    • 272
    • 278
  • WW41 70 83 96
    • 104
    • 111
    • 120
    • 132
    • 154
    • 155
    • 156
    • 157
    • 167
    • 170
    • 171
    • 176
    • 179
    • 190
    • 194
    • 195
    • 200
    • 208
    • 216
    • 222
    • 223
    • 224
    • 237
    • 244
    • 245
    • 247
    • 248
    • 249
    • 251
    • 253
    • 259
    • 261
    • 262
    • 264
    • 265
    • 272
    • 278
Amount recalled
41 units

Where it was sold

Why it was recalled

When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 26, 2013 · Data as of Sep 19, 5:24 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.