Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 28, 2018
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.
Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Healthcare Biosciences recalled DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imagi… - a moderate-severity action.
DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imagi… was recalled by Ge Healthcare Biosciences in November 28, 2018. Reason: Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the …. Check the official notice for the remedy. Verify recall #Z-0388-2019 with the FDA Devices before acting.
The recall
Ge Healthcare Biosciences issued this moderate-severity FDA Devices recall-Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the ….
- Moderate
- severity level
- 39 units
- affected scope
- Class II
- classification
- November 28, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0388-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0388-2019) was formally reported on November 28, 2018, with the manufacturer initiating the action on September 10, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Healthcare Biosciences is listed as the recalling firm, operating out of Westborough, MA. Federal records list the affected scope as 39.
The documented reason for this recall is: Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
39
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0388-2019 |
| Date reported | November 28, 2018 |
| Date initiated | September 10, 2018 |
| Recalling firm | Ge Healthcare Biosciences |
| Firm location | Westborough, MA |
| Affected scope | 39 |
| Distribution | Worldwide - US Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0388-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ge Healthcare Biosciences. Units affected: 39.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2018. Severity: Moderate. Recall number: Z-0388-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide - US Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0388-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 28, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.