The Recall Desk
HighFDA (Devices)·Z-2317-2021·Announced 2021-08-25

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.

What this means for you

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
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
  • software-error
  • contrast-overdose

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

Distributed nationwide across the United States.

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