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U.S. Department of Health and Human Services

Class 2 Device Recall ROTH MOBELI

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  Class 2 Device Recall ROTH MOBELI see related information
Date Initiated by Firm May 30, 2017
Create Date June 23, 2017
Recall Status1 Terminated 3 on October 09, 2018
Recall Number Z-2626-2017
Recall Event ID 77424
Product Classification Aid, transfer - Product Code IKX
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.
Code Information ROTH Catalogue Numbers 14002 96 S and 14002 25 S only.
Recalling Firm/
Manufacturer		 EOS Imaging
4 Ieme Etage
10 rue Mercoeur
Paris France
For Additional Information Contact
678-564-5400
Manufacturer 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.
FDA Determined
Cause 2		 Error in labeling
Action EOS Imaging sent Field Safety Notice letter and Removal Instructions May 30, 2017. Customers are to immediately discontinue use of the grab handles and remove them from all affected units from inventory and return to a EOS Imaging. For further questions please call (678) 564-5400.
Quantity in Commerce 8 units each
Distribution US Distribution to the states of : Pennsylvania, Massachusetts, Minnesota, Alabama, Michigan, Texas and Washington.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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