Draeger Medical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0436-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class I

Date Initiated: December 1, 2015

Date Posted: December 30, 2015

Recall Number: Z-0436-2016

Event ID: 72754

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.

Status: Terminated

Product Quantity: 2422

Code Information:

Catalog numbers: 8416400/8417400 distributed June 2011 October 2015.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated