Reported Apr 25, 2018 · Terminated

Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic device. It can produce…

Philips Electronics North America Corporation

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 Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • Ingenia 1.5T CX
  • Models 781261 & 781262 Product UsageIndicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities
Lot codes and dates
  • (Added 6/25/18): 41158 70743 70200
Amount recalled
8,205 units in total

This recall covers 13 products

The agency filed one notice per product. You are reading one of them; the other 12 are below.

Where it was sold

  • Nationwide
  • GA

Why it was recalled

Potential risk for helium gas inside the MR examination room during a magnet quench

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

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 10, 2020 · Data as of Sep 19, 6:17 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.