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Recall Observatory FDA recall evidence

Device product

ProxiDiagnost N90 is multi-functional general R/F systems.

Z-0240-2022

September 22, 2021

Class II

Product summary

Firm
Philips Healthcare
Event
Event 89023
Status
Ongoing
Classification
Class II
Quantity
281 in total
Official record key
device-enforcement:Z-0240-2022

Official wording

Reason: The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.

Code information: ProxiDiagnost N90

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.