Z-2626-2017Class II

ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96...

Name: Z-2626-2017 ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96...
Creator: EOS Imaging
Published: 2017-05-30
License: https://open.fda.gov/license/

EOS imaging / initiated 2017-05-30 / Terminated / root cause: labeling and UDI

FDA source

EOS Imaging began a recall of 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... on 2017-05-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2626-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-30
Posted: 2017-06-23
Terminated: 2018-10-09
Recalling firm: EOS imaging
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.
Product code: IKX Aid, Transfer
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: ROTH Catalogue Numbers 14002 96 S and 14002 25 S only.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2626-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2626-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-23

Product code IKX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)