FDAFDA · Food and drugs·Recall number Z-2626-2017
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.
Published July 5, 2017 · Recall initiated: May 30, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- EOS Imaging
- Distributor
- US Distribution to the states of : Pennsylvania, Massachusetts, Minnesota, Alabama, Michigan, Texas and Washington.
- Lot
- ROTH Catalogue Numbers 14002 96 S and 14002 25 S only,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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