CT Scanner Component Fracture Risk in Incisive System
Philips Incisive CT scanner systems may have a defective metal mounting box that could fracture and expel fragments during operation. Eighteen units are affected 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: FDA Class II medical device recall involving potential component fracture with no reported injuries or illnesses. The hazard is theoretical; the metal mounting box defect could theoretically cause harm through fragment expulsion, but no actual injury has been documented.
Plain-English summary
Philips North America LLC has recalled the Incisive CT X-ray system (Model 728143) due to a potential defect in the metal mounting box on the rotating scanner. The mounting box may become compromised during operation, potentially allowing contact with other internal gantry components and resulting in the expulsion of fragments.
A total of 18 units have been identified as affected and distributed nationwide. The affected units are identified by specific serial numbers as documented by Philips North America LLC.
The FDA has classified this as a Class II recall. Healthcare facilities should verify their system serial numbers against the recall notice to determine if their equipment is affected and consult with Philips North America LLC for corrective actions.
The recalled product
- Product
- Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
- Manufacturer
- Philips North America Llc
- Hazard
- metal-fragment
- mechanical-failure
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 (15)
- 500064
- 500074
- 500102
- 500110
- 500111
- 500145
- 500168
- 500178
- 500211 500216
- 500217
- 500222
- 500225
- 500230
- 500240
- 500242. Serial Number-Applied to FCO72800820 : 500615
Distribution
Distributed nationwide across the United States.
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