Reported Jul 5, 2017 · Terminated
ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS…
EOS Imaging
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: EOS Imaging · 4 Ieme Etage · Paris, N/A · N/A
Is this the product you have?
- ROTH MOBELI
- Grab Handles used with EOS System
MOBELI Stabi Vario Grab HandleROTH Catalogue Number 14002 96 SEOS Imaging Catalogue Number 9000111773and MOBELI Dual Grip Grab HandleROTH Catalogue Number 14002 25 SEOS Imaging Catalogue Number 9000111774
- Lot codes and dates
- ROTH Catalogue Numbers 14002 96 S and 14002 25 S only,
- Amount recalled
- 8 units each
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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