FDA recall Z-0388-2019

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

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

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