Recall – CT System software leads to incorrect scanning location

Company: GE Healthcare, LLC
Date of Enforcement Report: 2/6/2019
Class II:

PRODUCT

Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Recall Number: Z-0776-2019

REASON

On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator

RECALLING FIRM/MANUFACTURER

GE Healthcare, LLC on 7/12/2018. FDA Mandated.

VOLUME OF PRODUCT IN COMMERCE
131 units

DISTRIBUTION

US Nationwide and International

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
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