FDA-Device2023-04-26Class II

SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Hazard

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

Sold states

Worldwide - US Nationwide distribution.

Affected count

1461 units (236 US, 1225 OUS)

Manufactured in

Veenpluis 4-6, N/A, Best, N/A, Netherlands

Products

SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1416-2023

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