Philips North America Llc: Medical Device Recall in 2024 - (Recall #: Z-3198-2024)

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:

Ingenia Ambition 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: 782109

Product Classification:

Class II

Date Initiated: September 3, 2024

Date Posted: October 2, 2024

Recall Number: Z-3198-2024

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: 63 units

Code Information:

UDI-DI: (01)00884838098350(21) Serial Numbers; 47558 47602 47606 47608 47609 47614 47615 47617 47621 47622 47625 47626 47628 47630 47634 47644 47646 47651 47654 47656 47657 47660 47665 47666 47667 47668 47671 47672 47674 47677 47678 47679 47680 47681 47684 47685 47687 47688 47694 47695 47697 47698 47700 47701 47702 47703 47705 47706 47708 47709 47710 47716 47733 47737 47738 47753 47755 47759 47785 47791 47800 47802 47804

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