HIGHFDA DEVICE

Philips Ingenuity CT System Recall 2025: 285 Units Worldwide

Philips recalled 285 Ingenuity CT systems worldwide, including 728321, 728323 and 728326 models. A ball screw misalignment after a replacement can cause the patient couch to descend to the lowermost position. Hospitals and clinics should stop using the devices and follow Philips recall instructions.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
August 13, 2025
Status
ACTIVE
Severity
9/10

Quick Facts at a Glance

Recall Date
August 13, 2025
Hazard Level
HIGH
Brand
Philips
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
Product type
CT Scanner System
Model numbers
728321, 728323, 728326
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    August 13, 2025

  2. Reported by FDA DEVICE

    October 1, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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 Ingenuity CT System is a high-end CT scanner used in hospitals to perform diagnostic imaging. These systems require dependable table movement for patient positioning during scans.

Why This Is Dangerous

A misalignment of the ball screw after a replacement can cause the patient couch to descend unexpectedly to the lowest position, posing a risk of injury during scans.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals must halt use of affected units, implement interim imaging protocols, and coordinate with Philips for safe remediation. The recall could affect procedure schedules and equipment uptime.

Practical Guidance

How to identify if yours is affected

  1. Verify model numbers on the CT system label: 728321, 728323, 728326.
  2. Cross-check with Philips recall communications and the FDA notice.
  3. Review service history for any replacements involving the ball screw component.

Where to find product info

Look for the device label and the recall letter from Philips. The FDA recall page provides official details.

What timeline to expect

Hospitals should anticipate instructions and potential replacement or service within weeks. Recovery timelines vary by facility and device status.

If the manufacturer is unresponsive

  • Escalate to hospital procurement and clinical engineering teams.
  • Request direct guidance from Philips through the recall page or your regional representative.

How to prevent similar issues

  • Verify any service work on the couch involves ball screw alignment checks.
  • Monitor for recall updates and confirm remediation actions with Philips.

Documentation advice

Keep copies of recall notices, service records, and correspondence with Philips. Photograph any affected components and document dates.

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

Brand: Philips (Philips North America LLC). Product: Ingenuity CT System (Computed Tomography). Models: 728321, 728323, 728326. Sold since: Unknown. Price: Unknown. Location: Worldwide distribution, including US and listed countries.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Worldwide distribution including US
  • Ball screw misalignment after a replacement
  • Recall status: ACTIVE
  • Hazard level: HIGH

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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
9/ 10
Affected Groups
GENERAL
Injury Types
CRUSHINGFALL

Product Details

Brand
Model Numbers
728321
728323
728326
Affected States
ALL
Report Date
October 1, 2025
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

Philips Tempus Pro Patient Monitor Recalled Over Accuracy Issues

Philips recalled 7,129 Tempus Pro Patient Monitors on November 26, 2025. The monitors may provide unvalidated measurements for Intracranial Pressure and Bladder Pressure. Incorrect readings could lead to critical clinical decisions.

Philips
Patient monitor
Read more