FDA-Device2020-06-10Class II
System, Tomography Computed Emmission
GE Healthcare, LLC
Hazard
GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.
Sold states
Domestic Distribution: AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, IA, IL, IN, KY, LA,MA, MD, ME, MI, MN, MO, MS, NC, NE, NM, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT,VA, WI and WV. Foreign Distribution: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, France, Germany, Ghana, India, Israel, Italy, Japan, Korea, Malaisya, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Sweden, Taiwan, Thailand, Turkey and United Kingdom.
Affected count
526 total units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
System, Tomography Computed Emmission
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2258-2020Don't want to check this manually?
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