Quick Facts at a Glance
- Recall Date
- August 13, 2025
- Hazard Level
- HIGH
- Brand
- Philips North America
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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
- CT Scanner/Imaging System
- Model numbers
- 728306, 00884838059474, 100068, 100188, 100241, 100288, 100332, 100365 +12 more
- 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
Medical imaging CT systems are used to diagnose and guide treatment in clinical settings. The Brilliance iCT is a high-end CT platform.
Why This Is Dangerous
A misaligned ball screw after a replacement can cause the patient table to descend unexpectedly to its lowest position, posing crush or fall risks to patients.
Industry Context
This recall is part of a broader pattern of critical medical device recalls where post-replacement mechanical components fail.
Real-World Impact
The risk requires immediate cessation of use to protect patients and staff. Replacements or repairs may involve downtime and facility coordination.
Practical Guidance
How to identify if yours is affected
- Verify model numbers against the recall list (728306 and other listed models).
- Check device serial numbers and label markings on the patient table and control panel.
- Review recent service records to identify a replacement leading to misalignment.
Where to find product info
Refer to Philips recall communications and the FDA enforcement page Z-2598-2025 for exact instructions.
What timeline to expect
Refund or repair timelines vary by facility and model; expect weeks to months for service logistics.
If the manufacturer is unresponsive
- Escalate with hospital risk management
- Contact Philips support or regional distributor
- File complaint with the FDA if warranted
How to prevent similar issues
- Implement strict post-service verification to ensure ball screw alignment
- Follow manufacturer service procedures for replacements
- Schedule post-service testing and documentation
Documentation advice
Keep copies of all recall notices, service tickets, and correspondences with Philips and hospital administrators.
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Product Details
Brand: Philips North America. Product: Brilliance iCT CT systems. Model numbers included: 728306 and other listed models. Quantity: 210 units. Distribution: Worldwide, including the US and numerous countries listed. Recall date: 2025-08-13. Status: ACTIVE.
Reported Incidents
No specific injury counts are provided in the source document.
Key Facts
- Global distribution across 40+ countries
- Model general list includes 728306 and 100657 series
- Hazard level HIGH
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Safety Guide
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