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.
FDA Recall Z-0388-2019 · Posted None
Advertisement
Recalling FirmGE Healthcare Biosciences
Recall StatusTerminated
Product CodeREM
Date Initiated2018-09-10
Date Terminated2020-05-12
Product Quantity39
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.
Firm 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: [email protected].
Root Cause
Device Design
Distribution Pattern
Worldwide - US Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement