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.
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 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
- Affected units
- 18
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.
Part of a larger recall action
This product is one of 2 recalled by Philips North America Llc 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Same hazard · metal fragment
See all →- HighWegmans French toast mini muffins may contain foreign objects of metal
FDA (Food) · 2025-07-16
- HighWegmans chocolate chip mini muffins may contain foreign objects of metal
FDA (Food) · 2025-07-16
- HighWegmans blueberry mini muffins may contain foreign objects of metal origin
FDA (Food) · 2025-07-16
- HighSysco Low Cal Lemonade Recalled for Metal Fragments
FDA (Food) · 2024-12-11
- HighHalyard Pacemaker Tray Surgical Kits Recalled for Loose Metal Flakes
FDA (Devices) · 2024-11-20
Similar recalls
- HighPhilips CT scanner heat exchanger box may detach and cause injury
FDA (Devices) · 2023-08-09
- HighCT Scanner Metal Mounting Box May Become Expelled, Posing Injury Risk
FDA (Devices) · 2023-08-09
- HighPhilips Incisive CT Scanner Mounting Box Poses Injury Risk
FDA (Devices) · 2023-08-09
- HighIncisive CT Computed Tomography System: Metal Mounting Box May Detach
FDA (Devices) · 2023-08-09
- HighPhilips Incisive CT System Recalled for Gantry Actuator Failure Risk
FDA (Devices) · 2021-03-24
- HighPhilips CT Scanner May Display Images With Incorrect Orientation
FDA (Devices) · 2023-05-31