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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Philips North America: 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).

Agency Publication Date: May 15, 2023
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Affected Products

Product: ProxiDiagnost N90 R.1.0

REF number 706100 Serial number 10001015, 10001019, 10001020, 10001021, 10001022, 10001023, 10001026, 10001027, 10001028, 10001030, 10001033, 10001036, 10001037, 10001038, 10001039, 10001040, 10001042, 10001051, 20000067.

Product: CombiDiagnost R90 R.1.0

REF number 709030 Serial number 10001076

Product: CombiDiagnost R90 R1.1

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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92333
Status: Active
Manufacturer: Philips North America
Manufactured In: United States
Units Affected: 3 products (25 systems in total)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.