Summary
The FDA issued a Class II for Philips Spectral CT on Rails. Model Number: 728334. by PHILIPS MEDICAL SYSTEMS. 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 curren.
Details
Source
Device Recall
External ID
Z-1825-2026
Action Date
2026-04-22
Status
Ongoing
Category
device
Product Description
Philips Spectral CT on Rails. Model Number: 728334.
Lot/Code Info: 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.
Quantity Affected: 3 systems
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-07
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
PHILIPS MEDICAL SYSTEMS has 10 FDA actions in our database, including 8 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHILIPS MEDICAL SYSTEMS have FDA actions?
PHILIPS MEDICAL SYSTEMS has 10 FDA actions in our database, including 8 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1825-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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