CLASS II Device recall · Reported 28 Nov 2018 · FDA Enforcement Report
DeltaVision OMX SR Imaging System recalled by GE Healthcare Biosciences
GE Healthcare Biosciences is recalling DeltaVision OMX SR Imaging System, distributed nationwide in the US. The recall was initiated on 10 Sep 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0388-2019
- FDA event ID
- 81454
- Recalling firm
- GE Healthcare Biosciences, Westborough, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Sep 2018
- FDA classified
- 20 Nov 2018
- Reported
- 28 Nov 2018
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 10 Sep 2018 | Recall initiated by company | |
| 20 Nov 2018 | Classified by FDA | +71 days |
| 28 Nov 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide - US Nationwide Distribution
Questions about this recall
Is DeltaVision OMX SR Imaging System recalled?
Yes. GE Healthcare Biosciences recalled DeltaVision OMX SR Imaging System on 10 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-0388-2019.
Why was it recalled?
Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.
Which lots are affected?
System Serial number OM20072 - OM40122
Where was it sold?
Worldwide - US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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