FDA Recall
Open, Classified
Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
Recall: Z-0160-2024
·
Initiated September 8, 2023
Recall
- Recall Number
- Z-0160-2024
- Event Number
- 93123
- Firm
- Omega Medical Imaging, Inc.
- FEI Number
- 1000222289
- Product Code
- IWE
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- September 8, 2023
- Posted
- October 24, 2023
- Address
- 3400 Saint Johns Pkwy, Ste 1020, Sanford, FL, 32771-6769
Description
Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
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.
Action
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.
Distribution
Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma
Quantity
31 units