FDAJuly 13, 2015device
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
What to do
FDA enforcement status: Terminated
Brands named
draeger medicaldraeger
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDALidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.2026-05-12
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