Philips North America Llc: Device Recall

Recall #Z-2034-2025 · 05/29/2025

Class II: Risk

Recall Details

Recall Number: Z-2034-2025
Classification: Class II
Product Type: Device
Recalling Firm: Philips North America Llc
Status: Ongoing
Date Initiated: 05/29/2025
Location: Cambridge, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 370 units

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.

Product Description

Spectral CT. Computed tomography X-ray system.

Distribution Pattern

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.

Other Recalls by Philips North America Llc

Class II: Risk 12/12/2025

It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
Class II: Risk 10/31/2025

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025

Potential issue where the IntelliVue monitors did not alarm.
Class II: Risk 10/31/2025

Potential issue where the IntelliVue monitors did not alarm.

View all recalls by Philips North America Llc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.