DeltaVision OMX SR Imaging System Model Number: 29115476 The… — Class II medical device recall Z-0388-2019
Terminated recall by GE Healthcare Biosciences, reported 2018-11-28, distributed nationwide. Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the i
| Recall number | Z-0388-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | GE Healthcare Biosciences, Westborough, MA, United States |
| Recall initiated | 2018-09-10 |
| Classified | 2018-11-20 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Quantity | 39 |
| Serial numbers | OM20072, OM40122 |
| Model numbers | 29115476 |
Product
DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and localization microscopy may be used to examine a variety of samples over long periods of time.
Reason for recall
Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0388-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.