HIGHFDA DEVICE

Philips Spectral CT on Rails. Model Number: 728334.

PHILIPS MEDICAL SYSTEMSHealth & Personal CareMedical DevicesModel Number: 728334. UDI: (01)00884838103627(21)1005(01)00884838103627(21)1006(01)00884838103627(21)1007. Software Version Number: 5.1.X. Serial Numbers: 1005

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
March 7, 2026
Status
ACTIVE

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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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.

  1. Recall announced

    March 7, 2026

  2. Reported by FDA DEVICE

    April 22, 2026

  3. RecallRadar source check

    April 29, 2026

  4. 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.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

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.
Affected States
ALL
Report Date
April 22, 2026
Recall Status
ACTIVE