FDA-Device2023-04-26Class II
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
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
549 units (75 US, 474 OUS)
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1417-2023Don't want to check this manually?
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