Quick Facts at a Glance
- Recall Date
- August 13, 2025
- Hazard Level
- HIGH
- Brand
- Philips
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- 728235, 728231, 728317
- Sold at
- Unknown
- 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
Philips CT systems are medical imaging devices used in hospitals and clinics to generate CT scans for diagnostic purposes. The Brilliance CT and Ingenuity Flex platforms are common in radiology departments.
Why This Is Dangerous
A misalignment in the ball screw after a replacement can cause the patient couch to descend unexpectedly to the lowermost position, risking patient injury during procedures.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Hospitals must pause use of affected systems to prevent patient injuries during CT procedures and plan for remediation per Philips guidance.
Practical Guidance
How to identify if yours is affected
- Identify if your facility uses Brilliance CT 40 Channel (728235), Brilliance CT 64 Channel (728231), or Ingenuity Flex (728317).
- Check device labels for model numbers.
- Review recall notification for unit-specific instructions.
Where to find product info
Refer to the FDA recall page and the recall letter from Philips. Manufacturer service manuals and patient safety communications may also provide identifiers.
What timeline to expect
Timeline for remedy will be provided by Philips in the recall instructions and recall communications.
If the manufacturer is unresponsive
- Escalate to hospital administration and Philips support. If Philips is unresponsive, contact the FDA for guidance and consider legal consultation.
- Document all attempts to contact the manufacturer and clinical impact.
How to prevent similar issues
- Verify recall status before performing any post-replacement servicing on medical devices.
- Implement strict checklists for replacements that verify proper alignment of mechanical components.
- Maintain a documented recall-response plan for imaging equipment.
Documentation advice
Keep a copy of the recall notification, communication with Philips, service reports, and any incident logs.
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Product Details
Model numbers: 728235, 728231, 728317. Sold worldwide with US nationwide distribution and additional countries listed. Quantity: 181 units. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- World-wide distribution including US and countries list
- Recall status ACTIVE
- Hazard level HIGH
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Safety Guide
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