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Philips North America Recalls CT Scanner Over Rotor Fastener Issue

Philips North America recalled 47 CT scanners on January 7, 2026, due to improperly torqued rotor fasteners. This issue could lead to unsecured rotor parts, posing a high risk during operation. Patients and healthcare providers must stop using the device immediately.

Official notice
Philips North AmericaHealth & Personal CareMedical DevicesProduct Code (REF): 728306UDI-DI: 00884838059474Serial Numbers: 87064

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
January 7, 2026
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
January 7, 2026
Hazard Level
HIGH
Brand
Philips North America
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Philips North America
Product type
CT Scanner
Model numbers
Product Code (REF): 728306, UDI-DI: 00884838059474, Serial Numbers: 87064, 87120, 87121, 87122, 87125, 87126 +12 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 7, 2026

  2. Reported by FDA DEVICE

    February 18, 2026

  3. RecallRadar source check

    February 25, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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 rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America Llc or your healthcare provider for instructions. Notification method: Letter

About This Product

The Brilliance iCT CT Scanner is used for imaging in various medical settings. It is crucial for diagnostic purposes and patient care, making its reliability essential.

Why This Is Dangerous

The fasteners securing the rotor to the bearing may not be properly tightened, leading to a risk of rotor parts becoming unsecured and potentially causing serious incidents during operation.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall necessitates immediate action from healthcare providers, impacting patient care and potentially leading to equipment downtime.

Practical Guidance

How to identify if yours is affected

  1. Locate the product code and serial numbers on the device.
  2. Compare them against the list of recalled models.
  3. If your scanner matches, cease use immediately.

Where to find product info

Serial numbers can typically be found on the back or bottom of the device, often near the power supply or on a label.

What timeline to expect

Expect processing times for refunds or replacements to be approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Document your communications with Philips.
  • Try contacting customer service through different channels (phone, email).
  • Consult your healthcare institution's legal team if necessary.

How to prevent similar issues

  • Request torque specifications from manufacturers during installation.
  • Stay informed on industry-wide recalls and alerts.

Documentation advice

Keep records of all correspondence regarding the recall, including emails and phone call notes.

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Product Details

The recall affects the Brilliance iCT model with Product Code (REF): 728306. It was sold worldwide, including in several U.S. states and various countries. The recalled units were distributed between the product's manufacturing date and the recall date.

Key Facts

  • 47 CT scanners recalled
  • Risk of unsecured rotor parts
  • No reported incidents of expulsion
  • Immediate stop-use instructions issued
  • Sold worldwide including multiple U.S. states

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Product Code (REF): 728306
UDI-DI: 00884838059474
Serial Numbers: 87064
87120
87121
+15 more
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

Related Recalls

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Philips Recalls Spectral CT 7500 Over Fastener Issues

Philips North America recalled three Spectral CT 7500 units on January 7, 2026. The recall affects models with potential fastener issues that could lead to unsecured rotor parts. Patients and healthcare providers should stop using the device immediately.

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