GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of ...
FDA Recall #Z-0753-2016 — Class II — July 1, 2008
Product Description
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.
Reason for Recall
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.
Recalling Firm
Regulatory Insight, Inc — Littleton, CO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
43
Distribution
US Distribution to the states of :TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS and OH.
Code Information
NRT no.: 02980000
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated