Z-0160-2024 Class II Ongoing
FDA device recall Z-0160-2024 was initiated by Omega Medical Imaging, Inc. on September 8, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 31 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2023
- Initiation Date
- September 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 units
Product Description
Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
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.
Distribution Pattern
Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma
Code Information
all units manufactured between 10-22-2012 and 07-09-2019