EOS Imaging Recalls ROTH MOBELI Grab Handles for Detachment Risk
EOS Imaging is recalling ROTH MOBELI grab handles because they could detach, posing a fall risk to patients if operators do not follow instructions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of patient falls (injury) where no injuries have been reported yet, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
EOS Imaging is recalling ROTH MOBELI Grab Handles used with the EOS System. The specific products involved are the MOBELI Stabi Vario Grab Handle (ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773) and the MOBELI Dual Grip Grab Handle (ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774). A total of 8 units of each model are affected. These products were distributed in the United States to Pennsylvania, Massachusetts, Minnesota, Alabama, Michigan, Texas, and Washington.
The recall is due to a risk that the grab handles could detach, which could cause a patient to fall if the EOS system operator does not follow instructions. The handles are intended only for stabilizing a patient's hand or arm in the EOS cabin and should not be used to help a patient up. Before each use, the operator must examine the vacuum safety indicator to ensure the vacuum is monitored and sufficient and that the grab handle is correctly attached.
Operators should stop using these specific grab handles immediately and contact EOS Imaging for instructions on how to proceed. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 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.
- Manufacturer
- EOS Imaging
- Hazard
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ROTH Catalogue Numbers 14002 96 S and 14002 25 S only
Distribution
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