Philips CT Systems Recalled for Deteriorating Image Quality Phantom Pins
Philips Medical Systems is recalling 1,474 CT scanners because low-contrast pins in the Image Quality phantom deteriorate, preventing required daily checks.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the inability to perform daily quality checks due to component deterioration, which is a functional defect without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk or precautionary issues.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 1,474 units of Mx8000 IDT and Brilliance Whole Body Computed Tomography X-ray systems. The affected models include Brilliance CT 16, 10, and 6 slice systems, as well as Mx8000 IDT 16, 10, Quad, Dual, and Dual exp systems. These devices are distributed worldwide, including in the United States and numerous international countries.
The recall is due to a defect where the low-contrast pins in the Image Quality (IQ) phantom deteriorate over time. This deterioration prevents customers from performing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU). The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare facilities and customers with these specific serial numbers should contact Philips Medical Systems for instructions on how to resolve the issue. The recall number is Z-0786-2013.
The recalled product
- Product
- Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional i
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 1,474
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 (20)
- 1. Brilliance CT 16 slice (water): System Code #
- 728245
- Serial #s:2506
- 2518
- 2555
- 2558
- 2559
- 2561
- 2562
- 2564
- 2567
- 2573
- 2576
- 2578
- 2582
- 2583
- 2584
- 2585
- 2586
- 2587
Distribution
Related recalls
Same manufacturer · Philips Medical Systems (Cleveland) Inc
See all →- HighRadiation planning software recalled over image errors in three patient orientations
FDA (Devices) · 2025-09-24
- HighPinnacle 3 radiation planning software may miscalculate stopping power ratio
FDA (Devices) · 2025-08-13
- HighPinnacle3 Radiation Therapy Planning System dose-calculation software error
FDA (Devices) · 2022-09-21
- SeverePhilips Forte Gamma Camera System Recalled for Detector Fall Hazard
FDA (Devices) · 2019-11-13
- ModeratePhilips Forte Gamma Camera System Recalled for Detector Fall Hazard
FDA (Devices) · 2019-11-13
Same hazard · component deterioration
See all →- HighAllura Xper FD20 systems recalled over component deterioration halting motorized movements
FDA (Devices) · 2025-10-01
- HighAllura Xper FD20/20 OR Table recalled over deteriorating internal system components
FDA (Devices) · 2025-10-01
- HighAllura Xper FD20/20 systems recalled over battery, drive and power supply deterioration
FDA (Devices) · 2025-10-01
- ModerateAllura Xper FD20/15 X-ray System Motorized Movement Component Deterioration
FDA (Devices) · 2025-10-01
- HighAllura Xper FD10 systems recalled over ageing internal components stopping motorised movement
FDA (Devices) · 2025-10-01