CT Scanner Metal Mounting Box May Become Expelled, Posing Injury Risk
Philips is recalling Incisive CT Plus imaging systems due to a metal mounting box that may separate from the rotating scanner and potentially injure users.
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: This is a risk-of-harm medical device where a metal component may be expelled and cause injury to users, but no injuries have been reported. Although classified as FDA Class II, the lack of reported hospitalizations or injuries means it does not meet the threshold for Severe (score 4).
Plain-English summary
Philips North America is recalling the Incisive CT Plus-Computed Tomography X-Ray System, Model 728149, due to a metal mounting box located on the rotating scanner component that may become expelled during operation.
If the metal box becomes separated from the rotating scanner (rotor), it could contact other system components and potentially cause injury to operators or technicians. The detached component may also emit a loud noise and trigger automatic system shutdown.
The recall affects approximately 6 units distributed internationally. Healthcare facilities and operators using affected systems should immediately cease use and contact Philips North America for inspection, repair, or replacement. Affected unit serial numbers are: 530408, 530437, 530474, 530320, 530332, and 530430.
The recalled product
- Product
- Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
- Manufacturer
- Philips North America
- Affected units
- 6
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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