IQon Spectral CT System Software Error Increases Contrast Volume
Philips IQon Spectral CT systems can recommend excessive contrast volume when patient weight is set to pounds due to a SynchRight software calculation error, potentially resulting in patient overdose.
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: FDA Class II device recall for a software defect that can result in contrast medium overdose and potential patient harm. No illnesses or injuries are reported in the source, but the risk of harm from contrast overdose is substantial.
Plain-English summary
Philips North America LLC is recalling certain IQon Spectral CT (Computed Tomography) X-ray systems equipped with the SynchRight P3T (Personalized Patient Protocol) software module due to a calculation error. When patient weight unit preferences are set to pounds, the software produces an incorrect recommendation for increased contrast volume.
Contrast medium overdose can result in serious patient harm, including acute kidney injury, allergic reactions, and other complications. The issue represents a Class II defect in the dosing algorithm used by the device.
The recall affects IQon Spectral CT systems with specific serial numbers distributed across Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York, and Pennsylvania. Affected units are identified by their specific serial numbers and Software Version 4.7.7 SynchRight Option.
Facilities operating affected systems should verify their current weight unit settings and contact Philips for corrective software updates or additional guidance to ensure proper patient dosing.
The recalled product
- Product
- 728332 IQon Spectral CT-Computed Tomography X-ray system
- Manufacturer
- Philips North America Llc
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 (9)
- Serial Number/UDI: 60001 (01)00884838059542(21)60001
- 60005 (01)00884838059542(21)60005
- 60015 (01)00884838059542(21)60015
- 60017 (01)00884838059542(21)60017
- 860026 (01)00884838059542(21)860026
- 860035 (01)00884838059542(21)860035
- 860053 (01)00884838059542(21)860053 860074 (01)00884838059542(21)860074
- 860108 (01)00884838059542(21)860108
- 860109 (01)00884838059542(21)860109. Software Version 4.7.7 SynchRight Option
Distribution
Part of a larger recall action
This product is one of 5 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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