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 System / CT Scanner
- Model numbers
- 728311, 200016, 200024, 200211, 200041, 200030, 200060, 200048 +7 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
The Brilliance iCT SP CT System is a diagnostic imaging platform used by hospitals for CT scans. It combines advanced imaging with patient support equipment used during procedures.
Why This Is Dangerous
A misalignment in the ball screw after a replacement can cause the patient couch to descend unexpectedly, potentially injuring a patient during a scan or repositioning.
Industry Context
This recall is not described as part of a broader industry pattern in the available notice.
Real-World Impact
The hazard creates immediate safety concerns for patients and healthcare staff. Hospitals must halt use of affected units and coordinate with Philips for remediation.
Practical Guidance
How to identify if yours is affected
- Identify device as Brilliance iCT SP CT System with model 728311 or listed related models.
- Verify serial numbers against Philips recall documentation.
- Confirm recall status in official correspondence or FDA notice.
Where to find product info
Refer to the FDA enforcement page linked in the notice and Philips recall communications for device identifiers.
What timeline to expect
Remediation steps will be provided by Philips. Timelines vary by facility and replacement parts availability.
If the manufacturer is unresponsive
- Escalate to hospital biomedical engineering and Philips support.
- Document all communications and request documented remediation timelines.
How to prevent similar issues
- Implement routine servicing and verification after any component replacement.
- Maintain a log of a ball screw or couch-related components inspections.
- Establish a recall check protocol for all CT system component replacements.
Documentation advice
Keep the recall letter, model/serial numbers, and all correspondence with Philips and your hospital’s biomedical team.
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Product Details
Brand: Philips Product: Brilliance iCT SP CT System Model numbers included: 728311 and related models Related models listed in recall: 200016, 200024, 200211, 200041, 200030, 200060, 200048, 200069, 200098, 200097, 200112, 200136, 200200, 200209 Quantity recalled: 14 units Where sold: Worldwide distribution including the US and numerous countries Sold since: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model 728311 plus related models
- Global distribution including US and many countries
- Ball screw misalignment after replacement as root cause
- No injuries reported to date
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Safety Guide
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