FDA-Device2017-07-05Class II
ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
EOS Imaging
Hazard
ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Before each use, the operator must examine the vacuum safety indicator to check the vacuum is monitored and sufficient and the grab handle correctly attached. Do not use grab handles to help patient up. The handles are only for stabilizing the patients hand or arm in the EOS cabin.
Sold states
US Distribution to the states of : Pennsylvania, Massachusetts, Minnesota, Alabama, Michigan, Texas and Washington.
Affected count
8 units each
Manufactured in
4 Ieme Etage, 10 rue Mercoeur, Paris, N/A, France
Products
ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2626-2017Don't want to check this manually?
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