Sanford, FL, United States
Omega Medical Imaging, Inc. recalls
2 recalls recorded since 2018, most recently on 8 September 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 September 2023
- Reason
- 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
- Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0160-2024
- Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
Ongoing Class II Medical devices
- Recall started
- 28 February 2023
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the country of Pakistan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0156-2024
- Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.