Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
This recall is currently active, issued October 24, 2023. It was issued by Omega Medical Imaging, Inc..
- Company
- Omega Medical Imaging, Inc.
- Recall Initiated
- February 28, 2023
- Posted
- October 24, 2023
- Recall Number
- Z-0156-2024
- Quantity
- 52 units
- Firm Location
- Sanford, FL
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
all units manufactured between 10-22-2012 and 07-09-2019
Root Cause
Device Design
Action Taken
Omega Medical Imaging issued a Field Safety Advisory Notice to its consignees on 02/28/2023 by email. The notice explained the issue and pledged to evaluate all potentially impacted devices and mitigate the issue to bring the boom systems up to the latest safety design and standard of the newer models approved for field use.