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Recall Observatory FDA recall evidence

Device product

CombiDiagnost R90 R1.1

Z-1589-2023

March 03, 2023

Class II

Product summary

Firm
Philips North America
Event
Event 92333
Status
Ongoing
Classification
Class II
Quantity
25 systems in total
Official record key
device-enforcement:Z-1589-2023

Official wording

Reason: Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

Code information: REF number: 709031 Serial Number: 10001071, 10001072, 10001086, 10001087, 10001114

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).