FDA-Device2019-01-16Class II
Elekta Unity
Elekta Limited
Hazard
In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.
Sold states
TX and WI, Germany, Denmark, Netherlands, United Kingdom
Affected count
2 units
Manufactured in
Linac House, Fleming Way, Crawley, United Kingdom
Products
Elekta Unity
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0706-2019Don't want to check this manually?
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