Z-2343-2015Class I

PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult...

Name: Z-2343-2015 PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult...
Creator: Draeger Medical, Inc.
Published: 2015-07-13
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2015-07-13 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients on 2015-07-13. FDA classified it as Class I and gives the reason as "The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2343-2015
Classification: Class I
Status: Terminated
Initiated: 2015-07-13
Posted: 2015-08-14
Terminated: 2017-03-01
Recalling firm: Draeger, Inc.
Product: PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Draeger Medical, Inc. sent an Urgent Medical Device Recall Letter, dated July 2015, to end users to inform them of the issue and provide interim instructions to avoid the associated risk to patients. All PS500 batteries will be exchanged free of charge.
Quantity in commerce: 2081
Distribution: Nationwide Distribution.
Product codes and lots: Catalog Number(s): 8416400, 8417400

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2343-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2343-2015	Class I	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-14

Product code CBK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)