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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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.
Recall announced
August 13, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
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
- Verify model numbers on the CT system label: 728321, 728323, 728326.
- Cross-check with Philips recall communications and the FDA notice.
- 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.
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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
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