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.
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: 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
- Affected units
- 20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Philips North America 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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