Class II

Medical Device Recall: Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

Philips North America Llc · November 30, 2023

Reason for Recall

Multiple software issues that affect device functionality.

Distribution

Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Panama, Palestine, Portugal, South Korea, Spain, Switzerland, Thailand, United Kingdom.

States Affected

NATIONWIDE

Quantity Affected

197 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0725-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Philips North America Llc Medical Device Recall: Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. | SafeCheck