FDAClass IAugust 26, 2015

PS500 of an IACS Workstation Critical Care recall

PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.

Why was PS500 of an IACS Workstation Critical Care recalled?

The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number(s): 8416400, 8417400

Product
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Recalling firm
Draeger Medical, Inc.
Quantity
2081
Distribution
Nationwide Distribution.
Recall date
August 26, 2015
Classification
Class I
Status
Terminated
Agency
FDA (device)
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