Z-0436-2016Class I

Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is...

Name: Z-0436-2016 Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is...
Creator: Draeger Medical, Inc.
Published: 2015-12-01
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2015-12-01 / Terminated / root cause: software

FDA source

Draeger Medical, Inc. began a recall of Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation... on 2015-12-01. FDA classified it as Class I and gives the reason as "The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the...". 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-0436-2016
Classification: Class I
Status: Terminated
Initiated: 2015-12-01
Posted: 2015-12-23
Terminated: 2020-04-03
Recalling firm: Draeger, Inc.
Product: Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the charging algorithm in the current software. Devices used for patient transport will be a priority.
Root cause tag: software
FDA root cause: Software design
Action: Draeger Medical, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated November 2015 to all affected consignees. The letter identified the product, problem, and actions to be taken by the customers. The Battery Charging Software will be updated and, if necessary, the batteries replaced in all affected devices Free of Charge.
Quantity in commerce: 2422
Distribution: US Nationwide-including DC and PR, and the states of AK; AR; AZ; CA; CO; CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD; TN; TX; UT; VA; VT; WA; WI; and WV.
Product codes and lots: Catalog numbers: 8416400/8417400 distributed June 2011 October 2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0436-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0436-2016	Class I	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23

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)