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

Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;

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 for Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
FDA device enforcement

Product Name: Ingenia 1.5T CX; Model Number: 781262;

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 for Product Name: Ingenia 1.5T CX; Model Number: 781262;
FDA device enforcement

Product Name: Ingenia 3.0T CX; Model Number: 781271;

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 for Product Name: Ingenia 3.0T CX; Model Number: 781271;
FDA device enforcement

Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;

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 for Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
FDA device enforcement

Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;

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 for Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
FDA device enforcement

Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;

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 for Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
FDA device enforcement

Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;

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 for Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
FDA device enforcement

Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;

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 for Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
FDA device enforcement

Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidi...

Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of AE, AL, AO, AR, AT, AU, AW, BD, BE, BG, BH, BO, BR, BW, BY, CA, CD, CH, CI, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, E...

Official source for Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line...
FDA device enforcement

Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

Class IIReported ongoing

Distribution: Worldwide distribution: US (Nationwide); and OUS (Foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Czech Republi...

Official source for Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
FDA device enforcement

Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, exc...

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

Class IIReported ongoing

Distribution: US

Official source for Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualizatio...
FDA device enforcement

Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, exc...

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

Class IIReported ongoing

Distribution: US

Official source for Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualizatio...
FDA device enforcement

Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, ...

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

Class IIReported ongoing

Distribution: US

Official source for Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualiza...
FDA device enforcement

IntelliBridge EC10 Module. Model Number: 865115

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Class IIReported ongoing

Distribution: US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

Official source for IntelliBridge EC10 Module. Model Number: 865115
FDA device enforcement

IntelliVue Patient Monitor MX400. Model Number: 866060

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Class IIReported ongoing

Distribution: US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

Official source for IntelliVue Patient Monitor MX400. Model Number: 866060
FDA device enforcement

IntelliVue Patient Monitor MX450. Model Number: 866062

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Class IIReported ongoing

Distribution: US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

Official source for IntelliVue Patient Monitor MX450. Model Number: 866062
FDA device enforcement

IntelliVue Patient Monitor MX500. Model Number: 866064

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Class IIReported ongoing

Distribution: US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

Official source for IntelliVue Patient Monitor MX500. Model Number: 866064
FDA device enforcement

IntelliVue Patient Monitor MX550. Model Number: 866066

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Class IIReported ongoing

Distribution: US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

Official source for IntelliVue Patient Monitor MX550. Model Number: 866066

Reasons in these listed records

  • Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
  • Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
  • Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
  • Potential for collimator to fall as a result of incorrect installation.

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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