Z-1298-2014Class I

Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita...

Name: Z-1298-2014 Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita...
Creator: Draeger Medical Systems, Inc.
Published: 2014-02-07
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2014-02-07 / Terminated / root cause: design

FDA source

Draeger Medical Systems, Inc. began a recall of Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for... on 2014-02-07. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1298-2014
Classification: Class I
Status: Terminated
Initiated: 2014-02-07
Posted: 2014-03-28
Terminated: 2015-08-17
Recalling firm: Draeger Medical Systems, Inc.
Product: 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.
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: Drager sent an Urgent Medical Device Recall letter dated February 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use an affected device for patient transport only if absolutely necessary; not to rely on the battery charge status indicator, always supervise the patient and the ventilator during transport; ensure that they have a manual breathing bag available for manual ventilation as recommended in the instructions for use. If the power fail alarm occurs during transport, immediately provide manual ventilation and connect ventilator to a wall power source to resume ventilation. DragerService representative will schedule the implementation of a permanent solution as quickly as possible. The letter should be distributed to users of the Evita V500 and /or Babylog VN500 Ventilators to make them aware of this device behavior and risk mitigation measures. Customers with questions were instructed to call 1-800-543-5047. For questions regarding the operation and/or servicing of their Draer ventilator contact Technical Support at 1-800-543-5047. For questions regarding this recall call 215-721-5400.
Quantity in commerce: 1544
Distribution: Nationwide Distribution
Product codes and lots: all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1298-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1298-2014	Class I	Terminated	Voluntary: Firm initiated	2014-04-09	2014-03-28

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)