FDA recall Z-0156-2024

Omega Medical Imaging, Inc. · Class II · device

Product

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

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide and the country of Pakistan.

Key facts

Status
Ongoing
Initiation date
2023-02-28
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-0156-2024