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
- Affected units
- 3
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
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.
See all 5 products in this recall →Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips Recalls Cardiac Workstation 5000 Units for Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
Same hazard · dosing error
See all →- SevereLevothyroxine Sodium Tablets Recalled for Subpotency
FDA (Drugs) · 2026-07-29
- SevereMajor Pharmaceuticals Recalls Levothyroxine Sodium Tablets Over Subpotency
FDA (Drugs) · 2026-07-29
- HighPhothera 200 phototherapy calibration certificates had outputs reversed
FDA (Devices) · 2026-06-10
- HighMedline eye trays contain insulin syringes labeled as tuberculin syringes
FDA (Devices) · 2026-06-03
- CriticalPediatric ALS organizers recalled over potentially harmful drug dosing errors
FDA (Food) · 2026-02-04