Recall Z-0388-2019 ยท REM Spectroscopy Instrument
GE Healthcare Biosciences
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.
| Date | Sep 10, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | The firm, GE Healthcare, sent an "Important Electronic Product Radiation Warning" letter to affected customers on September 10, 2018. The letter identified the affected product, problem and actions to be taken. GE Healthcare will, without charge, remedy the defect or bring the product into compliance. Your GE Service Representative will contact you to implement the correction. For questions contact your local GEHC service representative or call 425-657-1512 or email: trisha.koenke@ge.com. |
| Quantity | 39 |
| Distribution | Worldwide - US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.