ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario… — Class II medical device recall Z-2626-2017
Terminated recall by EOS Imaging, reported 2017-07-05, distributed in AL, MA, MI, MN, PA, TX, WA. ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instru
| Recall number | Z-2626-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EOS Imaging, Paris, N/A, France |
| Recall initiated | 2017-05-30 |
| Classified | 2017-06-23 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2018-10-09 |
| Distributed | AL, MA, MI, MN, PA, TX, WA |
| Quantity | 8 units |
| Reason classes | device malfunction |
| Model numbers | 14002, 9000111773, 9000111774 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2626-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.