Spectral CT. Computed tomography X-ray system.
Reported: July 2, 2025 Initiated: May 29, 2025 #Z-2034-2025
Product Description
Spectral CT. Computed tomography X-ray system.
Reason for Recall
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 370 units
- Distribution
- Domestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Spectral CT. Computed tomography X-ray system.. Recalled by Philips North America Llc. Units affected: 370 units.
Why was this product recalled? ▼
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 2, 2025. Severity: Moderate. Recall number: Z-2034-2025.
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