Philips Incisive CT Scanner Metal Mounting Box May Expel Fragments
A metal mounting box on the rotating scanner in the Philips Incisive CT system may become damaged and contact other components, potentially expelling fragments at low velocity. This recall affects 155 units distributed nationwide.
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 medical device recall involves a potential structural defect (compromised metal mounting box) with risk of mechanical component failure and fragment expulsion. No injuries have been reported, but the hazard meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 155 units of the Incisive CT (Computed Tomography X-Ray System), Model Number 728144, with worldwide and US nationwide distribution. The system is designed to produce cross-sectional images of the body for medical imaging.
The metal mounting box (heat change box) on the rotating scanner rotor may become compromised. If damaged, this component may contact other gantry components during system rotation, potentially resulting in fragments being expelled at low velocity.
No illnesses or injuries have been reported to date. Medical imaging facilities using affected units should contact their equipment provider or Philips for guidance on inspection and corrective action procedures.
The recalled product
- Product
- Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — CT Scanner
- Hazard
- mechanical-defect
- fragment-hazard
Distribution
Distributed nationwide across the United States.
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