Incisive CT Power X-Ray System may display flipped or reversed images
The Incisive CT Power X-Ray System (Model 728148) may display computed tomography images with incorrect orientation—flipped or reversed—potentially leading to misdiagnosis, incorrect treatment, or additional radiation exposure from rescanning.
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: FDA Class II recall of a medical imaging device with potential for incorrect image orientation that could result in misdiagnosis or incorrect treatment. No hospitalizations or illnesses have been reported, placing it in the category of risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Incisive CT Power X-Ray System (Model 728148), manufactured by Philips, is the subject of a Class II recall due to a potential issue that may cause CT images to be displayed with incorrect orientation. Images may appear flipped or reversed from their correct presentation.
When CT images are displayed with incorrect orientation, physicians may misinterpret anatomical findings, potentially leading to misdiagnosis or incorrect clinical treatment decisions. If the orientation error is identified during clinical review and a rescan is performed to obtain correctly oriented images, the patient may receive additional, unnecessary radiation exposure.
The affected unit was distributed to medical facilities in Arkansas, California, Oklahoma, Texas, and to multiple countries including 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, and Vietnam.
Facilities with the Incisive CT Power system (Model 728148, Serial Number 102342065) should contact Philips for service assessment and corrective action. The recall is designated Z-1624-2023.
The recalled product
- Product
- Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
- Manufacturer
- PHILIPS HEADQUARTERS CAMBRIDGE
- Hazard
- diagnostic-error
- image-orientation
- radiation-exposure
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)
- UDI-DI: (01)00884838103467 (21) Serial Number: 102342065
Distribution
Distributed in 4 states:
- AR
- CA
- OK
- TX
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