08
Feb
2024

FDA Recall: Software Issue Incorrectly Labeled Captured Images

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Company: PHILIPS MEDICAL SYSTEMS
Date of Enforcement Report: 2/8/2024
Class II

PRODUCT

Spectral CT on Rails: Software Version 5.1.0.X, model 728334

Recall Number:

Z-1054-2024

REASON:

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

RECALLING FIRM/MANUFACTURER:

PHILIPS MEDICAL SYSTEMS

VOLUME OF PRODUCT IN COMMERCE:

US: 1

DISTRIBUTION:

Worldwide – US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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