Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 13, 2019
Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose c…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Draegar Medical Systems, Inc. recalled Omega Systems These devices are intended to be used in the environment where patient c… - a moderate-severity action.
Omega Systems These devices are intended to be used in the environment where patient c… was recalled by Draegar Medical Systems, Inc. in March 13, 2019. Reason: The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, w…. Check the official notice for the remedy. Verify recall #Z-0975-2019 with the FDA Devices before acting.
The recall
Draegar Medical Systems, Inc. issued this moderate-severity FDA Devices recall-The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, w….
- Moderate
- severity level
- Class II
- classification
- March 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0975-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0975-2019) was formally reported on March 13, 2019, with the manufacturer initiating the action on February 8, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Draegar Medical Systems, Inc. is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 10699 in total.
The documented reason for this recall is: The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication. Distribution data in the federal record shows the product reached: US Nationwide distribution including Puerto Rico.. 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 - 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 - 40,422 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
10699 in total
Related Recalls
6
0 from same agency
Product description
Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
Reason for recall
The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0975-2019 |
| Date reported | March 13, 2019 |
| Date initiated | February 8, 2019 |
| Recalling firm | Draegar Medical Systems, Inc. |
| Firm location | Andover, MA |
| Affected scope | 10699 in total |
| Distribution | US Nationwide distribution including Puerto Rico. |
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-0975-2019) 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? ▼
Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.. Recalled by Draegar Medical Systems, Inc.. Units affected: 10699 in total.
Why was this product recalled? ▼
The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2019. Severity: Moderate. Recall number: Z-0975-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0975-2019) 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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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 March 13, 2019. 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.