CLASS II ONGOING Device recall · Reported 13 Mar 2019 · FDA Enforcement Report
Omega Systems These devices are intended to be used recalled
Draegar Medical Systems is recalling Omega Systems These devices are intended to be used in the environment where patient care, distributed nationwide in the US. The recall was initiated on 8 Feb 2019 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-0975-2019
- FDA event ID
- 82014
- Recalling firm
- Draegar Medical Systems, Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Feb 2019
- FDA classified
- 5 Mar 2019
- Reported
- 13 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 8 Feb 2019 | Recall initiated by company | |
| 5 Mar 2019 | Classified by FDA | +25 days |
| 13 Mar 2019 | 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
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution including Puerto Rico.
Questions about this recall
Why was it 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 lots are affected?
All software versions, all serial numbers.
Where was it sold?
US Nationwide distribution including Puerto Rico.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 82014This product is part of a recall event; the main page for the event is Infinity Delta Family patient monitors The Infinity Delta recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Infinity Delta Family patient monitors The Infinity Delta recalled | Draegar Medical Systems | Device Malfunction | Nationwide |
More recalls from Draegar Medical Systems
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Drager Infinity CentralStation recalled by Draegar Medical Systems | Draegar Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Infinity Acute Care System (Iacs) Monitoring Solution recalled | Draegar Medical Systems | Other | Nationwide |
| Device | CLASS II | Infinity M300 telemetry monitoring device recalled | Draegar Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | The Infinity Acute Care System recalled by Draegar Medical Systems | Draegar Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Infinity Delta Family patient monitors The Infinity Delta recalled | Draegar Medical Systems | Device Malfunction | Nationwide |
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