Optional PS500 Power Supply Unit for the Evita V500… recallZ-0436-2016 · Draeger Medical, Inc. · initiated Dec 1, 2015
Class I Terminated All recalls posted in December 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Draeger Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0436-2016
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Dec 1, 2015
- Posted by the FDA
- Dec 23, 2015
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 2422
- Product code
- CBK
- FDA submissions
- K093632, K093633
- 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 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.
Code information (models, lots, serial numbers)
Catalog numbers: 8416400/8417400 distributed June 2011 October 2015.
Other devices under the same FDA submission
2 devices cleared under K093632, K093633 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- IACS Workstation Critical Care 8416400Drägerwerk AG & Co. KGaA · Ventilator, Continuous, Facility Use1 recall5 deaths213 reports
- IACS Workstation Neonatal Care 8417400Drägerwerk AG & Co. KGaA · Ventilator, Continuous, Facility Use1 recall66 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page