Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
FDA device recall Z-0160-2024 · 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. The lower boom became detached at the point shown and was restrained by the installed safety cable.
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- IWE
- Quantity affected
- 31 units
- Distribution
- Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma
- Date initiated
- 2023-09-08
- Date posted
- 2023-10-24
- Location
- Sanford, FL
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