CLASS I Device recall · Reported 26 Aug 2015 · FDA Enforcement Report

PS500 of an IACS Workstation Critical Care (Evita Infinity V500) recalled

Draeger Medical is recalling PS500 of an IACS Workstation Critical Care (Evita Infinity V500), distributed nationwide in the US. The recall was initiated on 13 Jul 2015 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesCatalog Number(s): 8416400, 8417400

Quantity recalled2081

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-2343-2015
FDA event ID: 71702
Recalling firm: Draeger Medical, Telford, PA
Classification: Class I
Status: Terminated
Recall initiated: 13 Jul 2015
FDA classified: 14 Aug 2015
Reported: 26 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

13 Jul 2015	Recall initiated by company
14 Aug 2015	Classified by FDA	+32 days
26 Aug 2015	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 of an IACS 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

PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.

Which lots are affected?

Catalog Number(s): 8416400, 8417400

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.

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