EOS Imaging: Medical Device Recall in 2017 - (Recall #: Z-2626-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 30, 2017

Date Posted: July 5, 2017

Recall Number: Z-2626-2017

Event ID: 77424

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.

Status: Terminated

Product Quantity: 8 units each

Code Information:

ROTH Catalogue Numbers 14002 96 S and 14002 25 S only,

Distribution Pattern:

US Distribution to the states of : Pennsylvania, Massachusetts, Minnesota, Alabama, Michigan, Texas and Washington.

Voluntary or Mandated:

Voluntary: Firm initiated