Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
Reported: February 14, 2024 Initiated: December 13, 2023 #Z-1055-2024
Product Description
Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
Reason for Recall
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Details
- Recalling Firm
- PHILIPS MEDICAL SYSTEMS
- Units Affected
- US: 33, OUS 177
- 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.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.. Recalled by PHILIPS MEDICAL SYSTEMS. Units affected: US: 33, OUS 177.
Why was this product recalled? ▼
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-1055-2024.
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