Quick Facts at a Glance
- Recall Date
- August 13, 2025
- Hazard Level
- HIGH
- Brand
- Philips North America
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
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 North America
- Product type
- Computed Tomography (CT) Scanners
- Model numbers
- IQon Spectral CT, Model 728332, 728332
- 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
IQon Spectral CT is a high-end diagnostic imaging system used in medical facilities for advanced CT imaging. The couch is part of the patient table assembly used during scans.
Why This Is Dangerous
Misalignment of the ball screw after replacement can cause the patient table to descend unexpectedly to the lowest position, risking patient harm during procedures.
Industry Context
This recall is not described as part of a broader pattern in the provided data.
Real-World Impact
Hospitals and clinics may need to quarantine affected units and coordinate replacements or repairs, potentially delaying imaging procedures.
Practical Guidance
How to identify if yours is affected
- Confirm model is IQon Spectral CT with Model 728332
- Check listed serial numbers against your unit
- Review recall notice for replacement instructions
Where to find product info
Refer to the FDA enforcement page for device identifiers, including the UDI-DI and serials.
What timeline to expect
No timeline is provided for refunds or repairs; coordinate with Philips for remediation.
If the manufacturer is unresponsive
- Escalate with hospital risk management
- Contact Philips support via official channels
- Consult the local regulatory authority if needed
How to prevent similar issues
- Verify replacement procedures with service technicians
- Document all replacements and inspections
- Follow manufacturer instructions for any service performed on CT tables
Documentation advice
Keep device serial numbers, replacement service records, and recall correspondence as part of the facility’s safety documentation.
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Product Details
Model numbers: IQon Spectral CT, Model 728332. Serial numbers include 860088, 860023, 860077, 860086, 60019, 860152, 860215, 60031, 60123, 60129, 60152, 860011, 860049, 860019, 860008, 860030, 860025, 860009. UDI-DI: 00884838059542. Distribution: Worldwide, including US nationwide and numerous countries listed in the recall notice. Quantity: 81 units.
Reported Incidents
No injuries or incidents have been reported in the provided recall notice.
Key Facts
- 81 units recalled worldwide
- Model 728332 IQon Spectral CT
- Ball screw misalignment after replacement
- Hazard level: HIGH
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Safety Guide
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