Skip to content
Recall Observatory FDA recall evidence

Device product

Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085

Z-0156-2024

February 28, 2023

Class II

Product summary

Firm
Omega Medical Imaging, Inc.
Event
Event 93018
Status
Ongoing
Classification
Class II
Quantity
52 units
Official record key
device-enforcement:Z-0156-2024

Official wording

Reason: An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location.

Code information: all units manufactured between 10-22-2012 and 07-09-2019

Distribution pattern: Worldwide distribution - US Nationwide and the country of Pakistan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location.