Incisive CT Computed Tomography System: Metal Mounting Box May Detach
A metal mounting box in the Incisive CT scanner may become expelled, potentially injuring users or causing the system to shut down. Philips is recalling 20 affected units distributed internationally.
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 for a mechanical hazard with concrete potential to cause user injury. No injuries have been reported, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America is recalling the Incisive CT for Brazil SKD-Computed Tomography X-Ray System, Model 728146. The recall applies to 20 units distributed internationally.
The metal mounting box (heat exchanger box) positioned on the rotating scanner rotor may become expelled. The expelled component could contact other internal components and cause injury to users. If the component detaches, a loud noise will be emitted and the system will shut down.
The affected units are identified by the following serial numbers: 540009, 540008, 540015, 540012, 540016, 540017, 540003, 540004, 540005, 540006, 540007, 540001, 540011, 540000, 540014, 540013, 540018, 540010, 540002.
The recalled product
- Product
- Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
- Manufacturer
- Philips North America
- Hazard
- mechanical-ejection
- injury-risk
- system-failure
Distribution
Distributed nationwide across the United States.
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