Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
Summary
The FDA issued a Class II for Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite Chi by Philips North America Llc. Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement..
Details
Source
Device Recall
External ID
Z-2602-2025
Action Date
2025-10-01
Status
Ongoing
Category
device
Product Description
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
Lot/Code Info: 1. Model Number: 728324; UDI-DI: 00884838059863; Serial Numbers: 336821, 337127, 336823, 336824, 336828, 336817, 336952, 336826, 336847, 336857, 336876, 336894, 336948, 336936, 336947, 337012, 337074, 337090, 337116, 337136, 345016, 345032, 345099, 345104.
Quantity Affected: 24 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-13
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America Llc has 302 FDA actions in our database, including 302 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 302 FDA actions in our database, including 302 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2602-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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