PHILIPS MEDICAL SYSTEMS: Medical Device Recall in 2024 - (Recall #: Z-1054-2024)

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:

Spectral CT on Rails: Software Version 5.1.0.X, model 728334.

Product Classification:

Class II

Date Initiated: December 13, 2023

Date Posted: February 14, 2024

Recall Number: Z-1054-2024

Event ID: 93798

Reason for Recall:

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

Status: Ongoing

Product Quantity: US: 1

Code Information:

UDI-DI: 00884838103627, serial number: 1005.

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated