CT X-ray System Software Miscalculates Contrast Volume with Pounds Unit Setting
Philips 728333 Spectral CT 7500 systems with SynchRight software may incorrectly calculate and recommend increased contrast volume when patient weight is set to pounds. Affected system should be updated to prevent excess contrast dosing.
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: This is a risk-of-harm product where no injuries have been reported. The software calculation error could lead to excess contrast administration, which poses potential for contrast-related complications.
Plain-English summary
Philips is recalling a Spectral CT 7500 computed tomography X-ray system (serial number 10019, software version 5.0.0 SynchRight Option) due to a software calculation error. When the patient weight unit preference is set to pounds in the SynchRight P3T (Personalized Patient Protocol) software, the system will recommend an increased contrast volume for the patient.
Excess contrast in CT imaging can increase risk of contrast-related complications. This software error could lead to unintended higher contrast doses if clinical staff do not independently verify the system's recommendations.
The affected system is distributed in the United States across Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York, and Pennsylvania.
Imaging centers using this system should contact Philips North America for a software update. Until the correction is applied, clinical staff should independently verify all contrast volume recommendations, particularly when patient weight is set to pounds.
The recalled product
- Product
- 728333 Spectral CT 7500 -Computed Tomography X-ray system
- Manufacturer
- Philips North America Llc
- Hazard
- Affected units
- 1
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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