Recall Z-1915-2016— GE Healthcare, LLC

Name: FDA recall Z-1915-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-09

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2016-05-09, terminated 2018-09-04. It names one FDA 510(k) clearance: K133705. Product: GE 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: GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-05-09
Terminated: 2018-09-04
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 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

GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie

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