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, 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
- Product type
- CT Scanner
- Model numbers
- Model Number: 728325, Serial Numbers: 338014, Serial Numbers: 338028, Serial Numbers: 338019
- 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 Family Brazil CT system is used for diagnostic medical imaging. Model 728325 and its serials were part of a limited recall due to a mechanical misalignment.
Why This Is Dangerous
A ball screw misalignment after a replacement can cause the patient support couch to descend unexpectedly to the lowest position, posing a risk to patient safety.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics with affected units must halt use and arrange service per recall instructions. The recall involves three units in global distribution, potentially impacting patient procedures and workflow.
Practical Guidance
How to identify if yours is affected
- Confirm the device is a Philips Ingenuity CT Family Brazil system
- Check model number for 728325
- Verify serial numbers 338014, 338028, 338019 against the unit label
Where to find product info
Refer to the FDA enforcement recall page and Philips recall notices. Device labels list model and serial numbers.
What timeline to expect
No timeline is specified for replacement or repair in the recall notice.
If the manufacturer is unresponsive
- Escalate to FDA recall coordinators and Philips corporate support.
- Document all attempts to contact the manufacturer and healthcare facility leadership.
How to prevent similar issues
- Use only authorized service personnel and replacement parts.
- Verify service actions with Philips before performing replacements.
- Maintain an up-to-date service log and review recalls for other equipment.
Documentation advice
Keep the recall letter, note serial/model numbers, capture photos of device labels, and preserve all correspondence with Philips and healthcare providers.
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Product Details
Model Number: 728325; Serial Numbers: 338014, 338028, 338019; Where Sold: Worldwide distribution including US; When Sold: Unknown; Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US and 40+ countries
- Hazard: patient couch descent from misaligned ball screw after replacement
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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