Reported Oct 1, 2025 · Ongoing
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Philips
- CT systems labeled as the following1. Ingenuity Core128 / Elite China
- Model Number728324
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 728324— — 00884838059863UDI-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. - Amount recalled
- 24 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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