Z-2626-2017 Class II Terminated
FDA device recall Z-2626-2017 was initiated by EOS Imaging on May 30, 2017 and is designated Class II. Reason for recall: 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 th… The recall status is terminated (terminated October 9, 2018). Affected quantity: 8 units each.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2017
- Initiation Date
- May 30, 2017
- Termination Date
- October 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units each
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Distribution to the states of : Pennsylvania, Massachusetts, Minnesota, Alabama, Michigan, Texas and Washington.
Code Information
ROTH Catalogue Numbers 14002 96 S and 14002 25 S only,