Evita Infinity V500 Ventilator recallZ-0827-2016 · Draeger Medical, Inc. · initiated Feb 4, 2016
Class I Terminated All recalls posted in February 2016
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 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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0827-2016
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Feb 4, 2016
- Posted by the FDA
- Feb 25, 2016
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 2553
- Product code
- CBK
- FDA submissions
- K093632, K093633
- Distribution
- US Nationwide Distribution including Puerto Rico.
Product description
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Code information (models, lots, serial numbers)
Catalog #s 8416400 and 8417400
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.
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