Omega Medical Imaging Elevating Monitor Suspension Systems, 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
- September 8, 2023
- Posted
- October 24, 2023
- Recall Number
- Z-0160-2024
- Quantity
- 31 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. 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
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 09/08/2023 via email. The notice explained the problem and the risk. The firm will inspect all affected devices to ensure the proper fasteners were installed on the unit.