CLASS II ONGOING Device recall · Reported 13 Mar 2019 · FDA Enforcement Report
Infinity Delta Family patient monitors The Infinity Delta recalled
Draegar Medical Systems is recalling Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa), 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-0974-2019
- 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
- Patient Monitors
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
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.
Where it was distributed
US Nationwide distribution including Puerto Rico.
Questions about this recall
Is Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) recalled?
Yes. Draegar Medical Systems recalled Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) on 8 Feb 2019. The recall is Class II and its status is Ongoing. Recall number Z-0974-2019.
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 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.
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 | Omega Systems These devices are intended to be used recalled | Draegar Medical Systems | Device Malfunction | Nationwide |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |