CT5000 X-ray System Contrast Dose Calculation Error Under Pounds Setting
Philips CT5000 X-ray systems may incorrectly calculate contrast volume doses when patient weight units are set to pounds. The software error could recommend higher-than-intended contrast volumes.
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 an FDA Class II medical device with a software error that results in incorrect dosing calculations. While no illnesses have been reported, the error could result in increased contrast exposure affecting patient safety, fitting the criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
This recall involves 2 Philips CT5000 Ingenuity Plus/Pro/Premium Computed Tomography X-ray systems. The systems are affected by a software issue in the SynchRight P3T (Personalized Patient Protocol) module.
When a patient weight unit preference is set to pounds, the SynchRight software incorrectly calculates the recommended contrast volume, resulting in recommendations for increased contrast volumes. This could potentially expose patients to higher-than-intended contrast doses.
The recalled systems are located in the states of Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York, and Pennsylvania. Affected healthcare facilities should contact Philips for instructions on how to address this issue. No illnesses or injuries have been reported.
Facilities with affected systems should verify their weight unit settings and contact Philips North America LLC for guidance on correcting the software configuration or obtaining a software update.
The recalled product
- Product
- Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
- Manufacturer
- Philips North America Llc
- Affected units
- 2
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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