Quick Facts at a Glance
- Recall Date
- March 7, 2026
- Hazard Level
- HIGH
- Brand
- PHILIPS MEDICAL SYSTEMS
- Geographic Scope
- 1 states
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 MEDICAL SYSTEMS
- Model numbers
- Model Number: 728334. UDI: (01)00884838103627(21)1005, (01)00884838103627(21)1006, (01)00884838103627(21)1007. Software Version Number: 5.1.X. Serial Numbers: 1005, 1006, 1007.
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 7, 2026
Reported by FDA DEVICE
April 22, 2026
RecallRadar source check
April 29, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS or your healthcare provider for instructions. Notification method: Letter
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Full Description
Philips Spectral CT on Rails. Model Number: 728334.. Reason: Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.. Classification: Class II. Quantity: 3 systems. Distribution: Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
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Safety Guide
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