Z-0156-2024 Class II Ongoing
FDA device recall Z-0156-2024 was initiated by Omega Medical Imaging, Inc. on February 28, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 52 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2023
- Initiation Date
- February 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52 units
Product Description
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Pakistan.
Code Information
all units manufactured between 10-22-2012 and 07-09-2019