Reported Feb 13, 2013 · Terminated

Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications

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?

  • Phillips Easy Diagnost Eleva DRF
  • Model Number706034
  • Product UsageUniversal Fluoroscopic Applications
Lot codes and dates
    • Serial Numbers 362600
    • 362601
    • 364209
    • 364210
    • 375245
    • 375850
    • 376439
    • 384396
    • 387492
    • 398185
    • 399440
    • 399621
    • 399623
    • 402409
Amount recalled
14 units

Where it was sold

Why it was recalled

The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.

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 Jan 23, 2017 · Data as of Sep 19, 5:26 PM UTC

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