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Philips North America Llc recall records

256 reported ongoing

261 records in this archive. Latest source date Aug 7, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Numbe...

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

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany...

Official source
FDA device enforcement

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 Num...

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

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany...

Official source
FDA device enforcement

Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

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

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany...

Official source
FDA device enforcement

Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.

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

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany...

Official source
FDA device enforcement

Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.

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

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany...

Official source
FDA device enforcement

Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

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

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany...

Official source
FDA device enforcement

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

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

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany...

Official source
FDA device enforcement

Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.

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

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany...

Official source
FDA device enforcement

Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.

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

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany...

Official source
FDA device enforcement

Spectral CT. Computed tomography X-ray system.

Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.

Class IIReported ongoing

Distribution: Domestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germ...

Official source
FDA device enforcement

Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republ...

Official source
FDA device enforcement

Product Name: SmartPath to dStream for 3.0T; Model Number: 782145

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republ...

Official source
FDA device enforcement

Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republ...

Official source
FDA device enforcement

Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republ...

Official source
FDA device enforcement

Product Name: Upgrade to MR 7700; Model Number: 782130;

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republ...

Official source
FDA device enforcement

Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republ...

Official source
FDA device enforcement

Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republ...

Official source
FDA device enforcement

Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republ...

Official source
FDA device enforcement

Product Name: Ingenia 1.5T S; Model Number: 781347;

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republ...

Official source
FDA device enforcement

Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republ...

Official source

Reasons in these listed records

  • The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
  • Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
  • Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

These examples come from this result page and are not a ranking of every recall reason.

Checking Philips North America Llc

Is there a recall on philips north america llc right now?

This archive contains 261 records, including 256 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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