Philips North America Llc: Medical Device Recall in 2025 - (Recall #: Z-2597-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.

Product Classification:

Class II

Date Initiated: August 13, 2025

Date Posted: October 1, 2025

Recall Number: Z-2597-2025

Event ID: 97468

Reason for Recall:

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Status: Ongoing

Product Quantity: 33 units

Code Information:

1. Model Number: 728242; UDI-DI: 00884838095168; Serial Number: 766018. 2. Model Number: 728243; UDI-DI: N/A; Serial Numbers: 7179, 7238, 7273, 7418, 7467, 7608, 7634, 7618, 7801, 7925, 75111, 75045, 75119, 75035, 75132, 750019, 76023. 3. Model Number: 728244; UDI-DI: 00884838059450; Serial Numbers: 7271, 7979, 76234, 750003, 7878, 76054, 760019, 76135, 76230, 76147, 76171, 760057, 760058, 76270, 760075.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated