Draeger Medical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0827-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.

Product Classification:

Class I

Date Initiated: February 4, 2016

Date Posted: March 2, 2016

Recall Number: Z-0827-2016

Event ID: 73241

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.

Status: Terminated

Product Quantity: 2553

Code Information:

Catalog #s 8416400 and 8417400

Distribution Pattern:

US Nationwide Distribution including Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated