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 Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

Class IIReported ongoing

Distribution: US and US Territories.

Official source for Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software ...
FDA device enforcement

Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

Class IIReported ongoing

Distribution: US and US Territories.

Official source for Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Inge...
FDA device enforcement

Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

Class IIReported ongoing

Distribution: US and US Territories.

Official source for Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrade...
FDA device enforcement

Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GH...

Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.

Official source for Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descr...
FDA device enforcement

Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and The countries of AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, ID, IL, IN, IT, JO, JP, KR, KR, LT, LU, L...

Official source for Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
FDA device enforcement

Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and The countries of AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, ID, IL, IN, IT, JO, JP, KR, KR, LT, LU, L...

Official source for Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
FDA device enforcement

Brilliance iCT; Product Code (REF): 728306;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the ...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Austr...

Official source for Brilliance iCT; Product Code (REF): 728306;
FDA device enforcement

IQon Spectral CT; Product Code (REF): 728332;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the ...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Austr...

Official source for IQon Spectral CT; Product Code (REF): 728332;
FDA device enforcement

Spectral CT; Product Code (REF): 728333;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the ...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Austr...

Official source for Spectral CT; Product Code (REF): 728333;
FDA device enforcement

Spectral CT 7500 on Rails; Product Code (REF): 728334;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the ...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Austr...

Official source for Spectral CT 7500 on Rails; Product Code (REF): 728334;

Reasons in these listed records

  • Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
  • Device will intermittently provide inaccurate data related to native heart rate.
  • Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
  • Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

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.

Keep checking