Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
FDA device recall Z-0156-2024 · posted 2023-10-24 · Open, Classified
Recall details
- Recalling firm
- Omega Medical Imaging, Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- IWE
- Quantity affected
- 52 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Pakistan.
- Date initiated
- 2023-02-28
- Date posted
- 2023-10-24
- Location
- Sanford, FL
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