PHILIPS MEDICAL SYSTEMS recall records

11 reported ongoing

11 records in this archive. Latest source date Jun 11, 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

Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potentia...

Class IIReported ongoing

Distribution: US Nationwide Distribution including Puerto Rico

Official source for Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brillian...
FDA device enforcement

Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potentia...

Class IIReported ongoing

Distribution: US Nationwide Distribution including Puerto Rico

Official source for Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upg...
FDA device enforcement

Philips Spectral CT on Rails. Model Number: 728334.

Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.

Official source for Philips Spectral CT on Rails. Model Number: 728334.
FDA device enforcement

Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;

Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equ...

Class IIReported ongoing

Distribution: Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA; International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland...

Official source for Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1....
FDA device enforcement

Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;

Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equ...

Class IIReported ongoing

Distribution: Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA; International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland...

Official source for Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA device enforcement

Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;

Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equ...

Class IIReported ongoing

Distribution: Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA; International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland...

Official source for Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
FDA device enforcement

Spectral CT on Rails: Software Version 5.1.0.X, model 728334.

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Repub...

Official source for Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
FDA device enforcement

Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Repub...

Official source for Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version...
FDA device enforcement

CombiDiagnost R90 1.0 (709030)

While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.

Official source for CombiDiagnost R90 1.0 (709030)
FDA device enforcement

CombiDiagnost R90 1.1 (709031)

While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.

Official source for CombiDiagnost R90 1.1 (709031)

Reasons in these listed records

  • The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan...
  • Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? or should ...
  • Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) va...
  • A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

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

Checking PHILIPS MEDICAL SYSTEMS

Is there a recall on philips medical systems right now?

This archive contains 11 records, including 11 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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