Draeger Evita Infinity V500 Ventilator Battery Recall
Draeger Medical is recalling 2,081 Evita Infinity V500 ventilators because the optional PS500 battery capacity did not last as long as expected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which is typically associated with a reasonable probability of serious adverse health consequences. However, the specific defect is a battery capacity issue without reported injuries or deaths, and the source text does not explicitly state that the defect poses an immediate life-threatening risk, placing it in the moderate range for a medical device with a functional defect rather than a catastrophic failure.
Plain-English summary
Draeger Medical, Inc. is recalling 2,081 units of the PS500 of an IACS Workstation Critical Care (Evita Infinity V500). This medical device is intended for the ventilation of adult, pediatric, and neonatal patients. The affected units are identified by Catalog Numbers 8416400 and 8417400.
The recall was initiated because the battery capacity of the optional PS500 component did not last as long as expected. The source text does not specify the exact duration of the battery life or the specific impact on patient care.
The affected products were distributed nationwide. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units or what to do if they are currently in use.
The recalled product
- Product
- PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
- Manufacturer
- Draeger Medical, Inc.
- Category
- Medical Device — Ventilator
- Hazard
- Affected units
- 2,081
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number(s): 8416400
- 8417400
Distribution
Distributed nationwide across the United States.
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