Recall Z-0388-2019— GE Healthcare Biosciences
Class II · Terminated
Class II FDA medical device recall by GE Healthcare Biosciences, initiated 2018-09-10, terminated 2020-05-12. FDA's recall record names no specific 510(k) clearance for this event. 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: Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant..
- Recalling firm
- GE Healthcare Biosciences
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-10
- Terminated
- 2020-05-12
- Firm location
- Westborough, MA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.