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Recall Observatory FDA recall evidence

Device product

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

Z-2343-2015

July 13, 2015

Class I

Product summary

Firm
Draeger Medical, Inc.
Event
Event 71702
Status
Terminated
Classification
Class I
Quantity
2081
Official record key
device-enforcement:Z-2343-2015

Official wording

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

Code information: Catalog Number(s): 8416400, 8417400

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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