GE Healthcare SIGNA Creator recalled over fire hazard

Recall date

August 31, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

GE Healthcare, LLC recalls GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.

Recall number

Z-2731-2016

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

US: AZ, CA, CT, FL, IL, MA, MS, MO, NC, PR, TX, WI. OUS: Algeria, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican republic, Egypt, France, Germany, Ghana, Guatemala, HONG KONG, Hungary, India, Indonesia, Iran, Italy, Jamaica, Japan, Korea, Kuwait, LEBANON, Lithuania, Maldives, M…

Why it was recalled

GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.