Recall Z-0156-2024— Omega Medical Imaging, Inc.
Class II · Ongoing
Class II FDA medical device recall by Omega Medical Imaging, Inc., initiated 2023-02-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Omega Medical Imaging, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-28
- Firm location
- Sanford, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.