Philips North America Llc: Medical Device Recall in 2024 - (Recall #: Z-3205-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782118

Product Classification:

Class II

Date Initiated: September 3, 2024

Date Posted: October 2, 2024

Recall Number: Z-3205-2024

Event ID: 95289

Reason for Recall:

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.

Status: Ongoing

Product Quantity: 2 units

Code Information:

UDI-DI: (01)00884838099746(21) Serial Numbers: 85661 85676

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Maldives, Mauritius, Mexico, Morocco, Netherlands, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated