Z-0388-2019Class II

DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of...

Name: Z-0388-2019 DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of...
Creator: GE Healthcare Biosciences
Published: 2018-09-10
License: https://open.fda.gov/license/

Whatman, Inc. / initiated 2018-09-10 / Terminated / root cause: design

FDA source

GE Healthcare Biosciences began a recall of DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging... on 2018-09-10. FDA classified it as Class II and gives the reason as "Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0388-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-10
Posted: 2018-11-20
Terminated: 2020-05-12
Recalling firm: Whatman, Inc.
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.
Product code: REM Spectroscopy Instrument
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.
Root cause tag: design
FDA 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: [email protected].
Quantity in commerce: 39
Distribution: Worldwide - US Nationwide Distribution
Product codes and lots: System Serial number OM20072 - OM40122

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0388-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0388-2019	Class II	Terminated	FDA Mandated	2018-11-28	2018-11-20

Product code REM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)