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Regulatory Insight, Inc recalls GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures,
Recalled March 2, 2016 · FDA recall Z-0753-2016 · Regulatory Insight
Hazard
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. · FDA Class II
Units
43
Sold at
US Distribution to the states of :TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS and OH.
Description
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.
Product
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.
Manufacturer(s)
Regulatory Insight, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →