Z-0753-2016 Class II Terminated

Recalled by Regulatory Insight, Inc — Littleton, CO

Recall Details

Product Type
Devices
Report Date
March 2, 2016
Initiation Date
July 1, 2008
Termination Date
July 11, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43

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.

Distribution Pattern

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