CLASS II ONGOING Device recall · Reported 3 May 2023 · FDA Enforcement Report
Draeger Infinity CentralStation (ICS) recalled
Draeger Medical Systems is recalling Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and, distributed nationwide in the US. The recall was initiated on 5 Apr 2023 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-1471-2023
- FDA event ID
- 91938
- Recalling firm
- Draeger Medical Systems, Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Apr 2023
- FDA classified
- 27 Apr 2023
- Reported
- 3 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 5 Apr 2023 | Recall initiated by company | |
| 27 Apr 2023 | Classified by FDA | +22 days |
| 3 May 2023 | 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 software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.
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
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Is Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and recalled?
Yes. Draeger Medical Systems recalled Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and on 5 Apr 2023. The recall is Class II and its status is Ongoing. Recall number Z-1471-2023.
Why was it recalled?
The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.
Which lots are affected?
UDI-DI: 04049098001878; All Systems Running Software versions: ICS VG2.1.3 and lower
Where was it sold?
Worldwide - 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 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 Draeger Medical Systems
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Infinity Central Station recalled by Draeger Medical Systems | Draeger Medical Systems | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Infinity Acute Care System (IACS) Monitoring System recalled | Draeger Medical Systems | Other | Nationwide |
| Device | CLASS II | Draeger Softbed Resuscitaire and/or Birthing Room Warmer recalled | Draeger Medical Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Draeger Infinity M300 and M300+, for use recalled | Draeger Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Draeger Globe-Trotter and Globe-Trotter IC recalled | Draeger Medical Systems | Other | DE, IN |
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|---|---|---|---|---|---|
| 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 |