Medium RiskFDA Device

Philips Healthcare: The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

Agency Publication Date: June 3, 2016

Affected Products

Product: Philips Healthcare DigitalDiagnost stationary X-ray system

software version - 4.0.4, 4.1.2, 4.1.3.

Product: Philips Healthcare DuraDiagnost stationary X-ray system

software version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74083

Status: Resolved

Manufacturer: Philips Healthcare

Manufactured In: United States

Units Affected: 2 products (160; 5)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.