Z-0827-2016Class I

Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation

Name: Z-0827-2016 Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation
Creator: Draeger Medical, Inc.
Published: 2016-02-04
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2016-02-04 / Terminated / root cause: software

FDA source

Draeger Medical, Inc. began a recall of Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation on 2016-02-04. FDA classified it as Class I and gives the reason as "The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0827-2016
Classification: Class I
Status: Terminated
Initiated: 2016-02-04
Posted: 2016-02-25
Terminated: 2020-04-01
Recalling firm: Draeger, Inc.
Product: Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.
Root cause tag: software
FDA root cause: Software design
Action: Draeger Medical, Inc. will send an Urgent Medical Device Recall Letter to consignees in a method that confirms delivery. For consignees that have received new devices with firmware version 1.50 (127 devices) or through device updates (644 devices; reference Recall Z-0436-2016), those devices will be downgraded to firmware version 1.49 and the batteries replaced. Batteries will continue to be replaced for all consignees every six months until a final solution is available.
Quantity in commerce: 2553
Distribution: US Nationwide Distribution including Puerto Rico.
Product codes and lots: Catalog #s 8416400 and 8417400

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0827-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0827-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25

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)