PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 15, 2016 Initiated: May 9, 2016 #Z-1915-2016

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

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
197 (US = 68; OUS = 129)
Distribution
Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, IN, KS, NE, NY,NC, OH, OR, PA, TN, TX, UT, A, WA, WI; and countries of: Australia, Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Hong Kong, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Mexico, New Zealand, Norway, Peru, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by GE Healthcare, LLC. Units affected: 197 (US = 68; OUS = 129).
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 15, 2016. Severity: Moderate. Recall number: Z-1915-2016.

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