Recall Z-0401-2016— GE Medical Systems, LLC

Name: FDA recall Z-0401-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-23

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2015-10-23, terminated 2016-05-09. It names one FDA 510(k) clearance: K133705. Product: GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.. Reason: GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-10-23
Terminated: 2016-05-09
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K133705 — REVOLUTION CTGe Medical Systems, LLC·cleared 2014-04-11

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 Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.

Reason for recall

GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue.

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