Recall Z-0753-2016— Regulatory Insight, Inc

Name: FDA recall Z-0753-2016
Creator: U.S. Food and Drug Administration
Published: 2008-07-01

Class II · Terminated

Class II FDA medical device recall by Regulatory Insight, Inc, initiated 2008-07-01, terminated 2017-07-11. It names one FDA 510(k) clearance: K033486. 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.. Reason: 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
Classification: Class II
Status: Terminated
Initiated: 2008-07-01
Terminated: 2017-07-11
Firm location: Littleton, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K033486 — GE PRECISION MPINrt-Nordisk Rontgen Teknik A/S·cleared 2003-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.