FDA recall Z-0160-2024

Omega Medical Imaging, Inc. · Class II · device

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-09-08
Report date
2023-11-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sanford, FL, United States

Primary source

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