Philips Recalls IQon Spectral CT Systems Due to Radiation Issue
Philips is recalling IQon Spectral CT systems due to an unintended radiation issue that could affect equipment performance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves an unintended radiation issue, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips North America LLC is recalling specific Philips IQon Spectral CT systems, including product codes 728332 and 728331 running software version 4.7.7.x. The recall is being conducted by the U.S. Food and Drug Administration (FDA) and classified as Class II.
The recall was initiated because Philips identified an unintended radiation issue with the equipment. This issue could affect the performance of the CT systems. The affected products were distributed in the United States and US Territories.
Hospitals and healthcare facilities should contact Philips North America LLC for further instructions on how to address the radiation issue and ensure patient safety.
The recalled product
- Product
- Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
- Manufacturer
- Philips North America Llc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI:N/A
Distribution
Distribution scope not specified by the agency.
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