Philips North America Llc: Device Recall

Recall #Z-1660-2025 · 04/01/2025

Class II: Risk

Recall Details

Recall Number
Z-1660-2025
Classification
Class II
Product Type
Device
Recalling Firm
Philips North America Llc
Status
Ongoing
Date Initiated
04/01/2025
Location
Cambridge, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
630 units

Reason for Recall

Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

Product Description

Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

Distribution Pattern

Worldwide distribution: US (Nationwide); and OUS (Foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Czech Republic, Estonia, France, Germany, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Lebanon, Libya, Luxembourg, Mauritius, Mexico, Monaco, Morocco, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Puerto Rico, R¿union, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, T¿rkiye, Turkmenistan, United Kingdom, UAE & Yemen.

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.