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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