# FDA recall Z-0388-2019

> **GE Healthcare Biosciences** · Class II · device recall initiated 2018-09-10.

## 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.

## Distribution

Worldwide - US Nationwide Distribution

## Key facts

- **Recall number:** Z-0388-2019
- **Recalling firm:** GE Healthcare Biosciences
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-10
- **Report date:** 2018-11-28
- **Termination date:** 2020-05-12

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Westborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0388-2019

## Citation

> AI Analytics. FDA recall Z-0388-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0388-2019. Source: US FDA. Licensed CC0.

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