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Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac...

FDA Recall #Z-0695-2021 — Class II — November 23, 2020

Recall #Z-0695-2021 Date: November 23, 2020 Classification: Class II Status: Terminated

Product Description

Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Reason for Recall

A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling

Recalling Firm

GE Healthcare, LLC — Waukesha, WI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3 units

Distribution

Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.

Code Information

Model Number: 5995000-5; Serial Number's: REVVX1700078CN (System ID: 713MMREVCT/UDI: 01008406821185521117070021REVVX1700078CN) , 00000440315CN0 (System ID: 220078CT04), and REVVX1800040CN (System ID: M2322265/UDI: 01008406821185521118030021REVVX1800040CN).

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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