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
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
- Ingenuity Core128 / Elite China, Model Number: 728324
- 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
CT scanners are used in medical imaging to produce detailed internal body images. The Ingenuity Core128 / Elite China labeling refers to a Philips model used in clinical settings.
Why This Is Dangerous
The danger arises from a misaligned ball screw in the couch mechanism that can allow the patient table to descend suddenly after a replacement.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals and imaging centers may need to halt procedures using affected units until inspected or repaired, potentially impacting scheduling and patient throughput.
Practical Guidance
How to identify if yours is affected
- 1. Confirm model 728324 is labeled on the device.
- 3. Review serial numbers against the provided list.
Where to find product info
Serial numbers and UDI are on the device label and in the recall notice. The recall page provides additional identification details.
What timeline to expect
Not specified in recall notice.
If the manufacturer is unresponsive
- Document all communications with Philips and the healthcare provider.
- Escalate to hospital risk management if no response within a reasonable period.
- Consider contacting regulatory agencies if needed.
How to prevent similar issues
- Ensure recall status is reviewed during procurement and service events.
- Require service by authorized technicians who follow manufacturer recalls.
- Maintain a current asset log with model, serial, and UDI for all imaging equipment.
Documentation advice
Keep copies of the recall letter, device label, serial numbers, and all correspondence with Philips and hospital risk management.
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Product Details
Model: Ingenuity Core128 / Elite China, Model Number: 728324. UDI-DI: 00884838059863. Serial Numbers: 336821, 337127, 336823, 336824, 336828, 336817, 336952, 336826, 336847, 336857, 336876, 336894, 336948, 336936, 336947, 337012, 337074, 337090. Quantity: 24 units. Distribution: Worldwide, including US nationwide and the countries listed in the recall notice. Country of origin: China for the Elite China labeling. Status: Active. Hazard: The patient support couch may descend unexpectedly to the lowermost position due to ball screw misalignment after a replacement. Remedy: Stop using the device.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 24 units recalled worldwide
- Model 728324 (Ingenuity Core128 / Elite China)
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