Incisive CT Plus imaging system recalled for potential incorrect image orientation
Philips is recalling 5 Incisive CT Plus CT X-ray systems due to potential defects that may display images with flipped or reversed orientation, risking misdiagnosis, incorrect treatment, and unnecessary radiation exposure from repeat scans.
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 FDA Class II recall involves a medical imaging device with serious potential for patient harm through misdiagnosis, incorrect treatment, and additional radiation exposure. No illnesses or injuries have been reported, placing this within the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Incisive CT Plus Whole-body CT X-Ray System, Model 728149 (OUS), manufactured by Philips, is being recalled due to a potential defect that may cause images to display with incorrect orientation—either flipped or reversed.
When CT images are displayed with incorrect orientation, clinicians may misinterpret anatomical structures, leading to misdiagnosis and inappropriate treatment decisions. Additionally, if the orientation error is discovered after initial diagnosis, patients may require repeat scans, resulting in unnecessary radiation exposure.
Five units of the affected system have been distributed to healthcare facilities in the United States (Arkansas, California, Oklahoma, Texas) and internationally (Argentina, Australia, Austria, China, Colombia, Czech Republic, Dominican Republic, France, Germany, Guadeloupe, Hong Kong, India, Japan, Kuwait, Latvia, Lithuania, Netherlands, Norway, Portugal, Romania, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam). The affected serial numbers are 530537, 554032, 554060, 554065, and 554078.
Healthcare facilities and clinicians with affected systems should contact Philips for guidance on remediation, and should review prior imaging performed on these devices to verify diagnostic accuracy.
The recalled product
- Product
- Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
- Manufacturer
- PHILIPS HEADQUARTERS CAMBRIDGE
- Hazard
- incorrect-image-orientation
- misdiagnosis
- radiation-exposure
Distribution
Distributed in 4 states:
- AR
- CA
- OK
- TX
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