FDA Enforcement
Class II
Ongoing
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Recall: Z-0156-2024
·
Reported November 1, 2023
Enforcement
- Recall Number
- Z-0156-2024
- Event ID
- 93018
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Omega Medical Imaging, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- November 1, 2023
- Initiation Date
- February 28, 2023
- Classification Date
- October 24, 2023
- Address
- 3400 Saint Johns Pkwy Ste 1020, N/A, Sanford, FL, 32771-6769, United States
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.
Code Info
all units manufactured between 10-22-2012 and 07-09-2019
Distribution
Worldwide distribution - US Nationwide and the country of Pakistan.
Quantity
52 units