FDA recall Z-2602-2025

Philips North America Llc · Class II · device

Product

Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.

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.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2025-08-13
Report date
2025-10-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2602-2025