Device product
Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
Z-0160-2024
Product summary
- Event
- Event 93123
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 31 units
- Official record key
device-enforcement:Z-0160-2024
Official wording
Reason: 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.
Code information: all units manufactured between 10-22-2012 and 07-09-2019
Distribution pattern: Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma
Derived failure modes
-
Unknown
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.