The Recall Desk
HighFDA (Devices)·Z-2316-2021·Announced 2021-08-25

CT system software error recommends excessive contrast volume

A software defect in Philips CT imaging systems causes incorrect contrast volume calculations when patient weight units are set to pounds, resulting in increased contrast dosing recommendations. Three units with specific serial numbers are affected.

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: This is an FDA Class II recall involving a medical device software error that produces incorrect dosing calculations for contrast material. The hazard (increased contrast volume administration) poses a potential risk to patients. No injuries or illnesses have been reported, making this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips has recalled three Ingenuity CT Upgrades Computed Tomography X-ray systems due to a software defect in the SynchRight P3T (Personalized Patient Protocol) application. When patient weight unit preferences are set to pounds rather than kilograms, the software calculates and recommends an increased volume of contrast material for the patient.

The affected systems have serial numbers 300099, 300106, and 300143, operating SynchRight Option software version 4.1.10. These systems are located in medical facilities across Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York, and Pennsylvania.

Increased contrast volume can increase the risk of adverse effects from contrast administration. The FDA classified this as a Class II recall.

Healthcare facilities with affected systems should verify their device serial numbers and contact Philips for information about software corrections. Facilities should also review patient records from procedures performed with weight units set to pounds.

The recalled product

Product
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging / CT Scanner
Hazard
  • dosing-error
  • contrast-overdose
  • software-error

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)

  • Serial Number: 300099 300106 300143 Software Version 4.1.10 SynchRight Option

Distribution

Distributed nationwide across the United States.

Related recalls

Same category