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
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-1416-2023More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls
- FDA-Device2026-06-03Philips Azurion imaging systems recalled for hard drive failure risk affecting imaging functionality
- FDA-Device2026-06-03Philips Allura medical imaging systems recalled for hard drive failure risk
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for cooling hose degradation risk
- FDA-Device2026-05-27Philips Integris-Allura X-ray systems recalled for cooling unit oil leakage risk
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for impaired table movement due to control wear
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