PS500 of an IACS Workstation Critical Care (Evita Infinity… recallZ-2343-2015 · Draeger Medical, Inc. · initiated Jul 13, 2015
Class I Terminated All recalls posted in August 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 battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Draeger Medical, Inc. sent an Urgent Medical Device Recall Letter, dated July 2015, to end users to inform them of the issue and provide interim instructions to avoid the associated risk to patients. All PS500 batteries will be exchanged free of charge.
Recall details
- Recall number
- Z-2343-2015
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Jul 13, 2015
- Posted by the FDA
- Aug 14, 2015
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 2081
- Product code
- CBK
- FDA submissions
- K093632, K093633
- Distribution
- Nationwide Distribution.
Product description
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Code information (models, lots, serial numbers)
Catalog Number(s): 8416400, 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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