Reported Mar 2, 2016 · Terminated

GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures,…

Regulatory Insight, 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: Regulatory Insight, Inc · 33 Golden Eagle Ln · Littleton, CO · 80127-5745

Is this the product you have?

  • GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
Lot codes and dates
  • NRT no.: 02980000
Amount recalled
43

Where it was sold

Why it was recalled

It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.

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 Jul 11, 2017 · Data as of Sep 19, 5:20 PM UTC

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