Philips North America Llc: Medical Device Recall in 2024 - (Recall #: Z-1871-2024)

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:

Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143

Product Classification:

Class II

Date Initiated: April 15, 2024

Date Posted: May 29, 2024

Recall Number: Z-1871-2024

Event ID: 94536

Reason for Recall:

Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity

Status: Ongoing

Product Quantity: 18 units

Code Information:

UDI-DI: (01) 00884838085015 (21) + Serial number Serial Numbers- Applied to FCO72800819: 500046, 500064, 500074, 500102, 500110, 500111, 500145, 500168, 500178, 500211 500216, 500217, 500222, 500225, 500230, 500240, 500242. Serial Number-Applied to FCO72800820 : 500615

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated