FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0388-2019
- Recalling firm
- GE Healthcare Biosciences
- 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.
- Status
- Terminated
- Initiated
- 2018-09-10
- Posted
- not on file
- Terminated
- 2020-05-12
- 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
- Lot, serial or model codes
- System Serial number OM20072 - OM40122
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REM
- Firm FEI
- 1281317
- Firm city
- Westborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28