CLASS II ONGOING Device recall · Reported 20 Nov 2019 · FDA Enforcement Report
Infinity M300 telemetry monitoring device recalled
Draegar Medical Systems is recalling Infinity M300 telemetry monitoring device, distributed nationwide in the US. The recall was initiated on 9 Oct 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-0372-2020
- FDA event ID
- 84028
- Recalling firm
- Draegar Medical Systems, Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Oct 2019
- FDA classified
- 14 Nov 2019
- Reported
- 20 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 9 Oct 2019 | Recall initiated by company | |
| 14 Nov 2019 | Classified by FDA | +36 days |
| 20 Nov 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.
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 M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
Where it was distributed
US nationwide distribution.
Questions about this recall
Why was it recalled?
The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.
Which lots are affected?
All systems using Software version VG2.3.1 and lower
Where was it sold?
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 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.
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 | 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 |
| Device | CLASS II | Infinity Delta Family patient monitors The Infinity Delta recalled | Draegar Medical Systems | Device Malfunction | Nationwide |
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| 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 |