FDA-Device2022-07-27Class II
SIGNA Premier magnetic resonance scanner, model 5748519.
GE Healthcare, LLC
Hazard
Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, MI, MN, NY, and WI. There was government distribution but no military distribution. The countries of China, France, Hong Kong, India, Italy, Japan, Korea, Kuwait, Norway, Oman, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.
Affected count
52
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
SIGNA Premier magnetic resonance scanner, model 5748519.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1430-2022Don't want to check this manually?
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