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

Achieva 1.5T

Potential component failure in the Gradient Coil could product smoke and/or fire.

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombi...

Official source for Achieva 1.5T
FDA device enforcement

Achieva 1.5T Conversion

Potential component failure in the Gradient Coil could product smoke and/or fire.

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombi...

Official source for Achieva 1.5T Conversion
FDA device enforcement

Achieva 1.5T Initial System

Potential component failure in the Gradient Coil could product smoke and/or fire.

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombi...

Official source for Achieva 1.5T Initial System
FDA device enforcement

Ingenia 1.5T CX

Potential component failure in the Gradient Coil could product smoke and/or fire.

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombi...

Official source for Ingenia 1.5T CX
FDA device enforcement

Intera 1.5T

Potential component failure in the Gradient Coil could product smoke and/or fire.

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombi...

Official source for Intera 1.5T
FDA device enforcement

Intera 1.5T Power/Pulsar

Potential component failure in the Gradient Coil could product smoke and/or fire.

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombi...

Official source for Intera 1.5T Power/Pulsar
FDA device enforcement

SmartPath to dStream for 1.5T

Potential component failure in the Gradient Coil could product smoke and/or fire.

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombi...

Official source for SmartPath to dStream for 1.5T
FDA device enforcement

Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.

For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when...

Class IIReported ongoing

Distribution: Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan

Official source for Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed f...
FDA device enforcement

Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.

For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when...

Class IIReported ongoing

Distribution: Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan

Official source for Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator d...
FDA device enforcement

Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.

For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when...

Class IIReported ongoing

Distribution: Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan

Official source for Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and si...

Reasons in these listed records

  • Potential component failure in the Gradient Coil could product smoke and/or fire.
  • For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute pati...
  • Potential for units suspended on the ceiling to fail and fall.

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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