FDA-Device2016-09-14Class II
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
GE Healthcare, LLC
Hazard
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.
Sold states
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, Martinique, Mexico, MOROCCO, Netherlands, New Zealand, OMAN, Pakistan, Philippines, Poland, Portugal, Romania, SAUDI ARABIA, Singapore, South Africa, Spain,Sweden, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
Affected count
383 (US = 24;OUS = 359)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2731-2016Don't want to check this manually?
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