CLASS I Device recall · Reported 9 Apr 2014 · FDA Enforcement Report
Draeger PS500 Power Supply Unit of the Infinity ACS recalled
Draeger Medical Systems is recalling Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita, distributed nationwide in the US. The recall was initiated on 7 Feb 2014 and the FDA has classified it as Class I.
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-1298-2014
- FDA event ID
- 67502
- Recalling firm
- Draeger Medical Systems, Telford, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 7 Feb 2014
- FDA classified
- 28 Mar 2014
- Reported
- 9 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 7 Feb 2014 | Recall initiated by company | |
| 28 Mar 2014 | Classified by FDA | +49 days |
| 9 Apr 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
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 PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
Which lots are affected?
all lots
Where was it sold?
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 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 | Device Malfunction | 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 CentralStation (ICS) recalled | Draeger Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Draeger Infinity M300 and M300+, for use recalled | Draeger Medical Systems | Device Malfunction | Nationwide |
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| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |