Omega Medical Imaging, Inc.
Omega Medical Imaging, Inc. has 4 FDA enforcement events on this register (4 product records) between 2016 and 2023: 4 device; the busiest year was 2023 with 2.
0% of its events are Class I; the most common class is Class II (4). 2 events are listed as ongoing; the recalling firm's address is in FL.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 8 Sep 2023 | Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085 | Device | Class II | 1 | Ongoing |
| 28 Feb 2023 | Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085 | Device | Class II | 1 | Ongoing |
| 23 Mar 2017 | Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals. | Device | Class II | 1 | Terminated |
| 21 Jun 2016 | 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems. | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Omega Medical Imaging, Inc. had?
4 enforcement events (4 product records) on this register, 2016–2023: 4 device.
Are any Omega Medical Imaging, Inc. recalls ongoing?
2 events are listed as ongoing in the current openFDA export.
What class are Omega Medical Imaging, Inc. recalls?
4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.