FDA Recall
Open, Classified
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Recall: Z-0156-2024
·
Initiated February 28, 2023
Recall
- Recall Number
- Z-0156-2024
- Event Number
- 93018
- Firm
- Omega Medical Imaging, Inc.
- FEI Number
- 1000222289
- Product Code
- IWE
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- February 28, 2023
- Posted
- October 24, 2023
- Address
- 3400 Saint Johns Pkwy, Ste 1020, Sanford, FL, 32771-6769
Description
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Reason
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.
Action
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.
Distribution
Worldwide distribution - US Nationwide and the country of Pakistan.
Quantity
52 units