FDA-Device2023-04-26Class II
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
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-1417-2023More 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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