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Recall Observatory FDA recall evidence

Device product

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

Z-0160-2024

September 08, 2023

Class II

Product summary

Firm
Omega Medical Imaging, Inc.
Event
Event 93123
Status
Ongoing
Classification
Class II
Quantity
31 units
Official record key
device-enforcement:Z-0160-2024

Official wording

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

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

Distribution pattern: Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma

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. The lower boom became detached at the point shown and was restrained by the installed safety cable.