United StatesPhilips Spectral CT on Rails (Model 728334) with Software Version 5.1.X and UDI (01)00884838103627(21)1005–1007, serial numbers 1005–1007, sold in the US (Minnesota), France and the Netherlands, is being recalled. The recall was issued because three software issues were identified: during a continuous CT scan the gantry may remain at the current scan position after pressing Go; the “Previous Surview Exists Select Previous Surview? <Yes> or <No>” message may not appear; and after Surview and planning a Brain Helical acquisition with increased dose the Define Head Area option may be grayed out.
What's being recalled
Philips Spectral CT on Rails. Model Number: 728334.
Recalling firm: Philips Medical Systems, Cambridge, MA, United States.
How to identify it
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.
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)