Philips North America Llc: Device Recall

Recall #Z-0583-2025 · 11/16/2024

Class II: Risk

Recall Details

Recall Number: Z-0583-2025
Classification: Class II
Product Type: Device
Recalling Firm: Philips North America Llc
Status: Ongoing
Date Initiated: 11/16/2024
Location: Cambridge, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 301 units

Reason for Recall

Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

Product Description

Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AR, AZ, CA, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, 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.