FDA-Device2023-11-01Class II

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

Omega Medical Imaging, Inc.
Hazard

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.

Sold states
Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma
Affected count
31 units
Manufactured in
3400 Saint Johns Pkwy Ste 1020, N/A, Sanford, FL, United States
Products
Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0160-2024

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