Philips IQon Spectral CT Recalled for Image and Scan Errors
Philips is recalling 35 IQon Spectral CT systems due to software issues causing rescans, incorrect scan locations, or misrepresentation of image results.
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: The recall is classified as FDA Class II and involves a risk of harm (misrepresentation of image results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 35 IQon Spectral CT systems equipped with software version 4.7.0. The recall is due to multiple issues that have caused the device to result in CT rescans, incorrect scan location, or misrepresentation of image results.
The affected systems are distributed worldwide, including in the United States (AR, IN, LA, MA, MN, OR, TN, and TX) and in Australia, Belgium, Denmark, France, Germany, Israel, Japan, Republic of Korea, Poland, Portugal, Slovenia, Switzerland, Thailand, and the United Kingdom. Specific system serial numbers are listed in the recall documentation.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issues. Patients who have had scans on these systems should consult their healthcare provider regarding the potential impact on their diagnostic results.
The recalled product
- Product
- IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 35
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
- SeverePhilips Forte Gamma Camera System Recalled Due to Detector Falling Hazard
FDA (Devices) · 2019-11-13
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModeratePhilips IQon Spectral CT Software Defect Recall
FDA (Devices) · 2016-12-14
- HighPhilips IQon Spectral CT Software Recall for Image Misrepresentation
FDA (Devices) · 2018-03-14
- HighPhilips IQon Spectral CT Software Recall for Misleading Calcium Score Reports
FDA (Devices) · 2018-11-07
- ModeratePhilips IQon Spectral CT Recall for Cardiac Image Labeling Error
FDA (Devices) · 2019-08-14
- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- LowPhilips IQon Spectral CT System Recalled for Incorrect Label Rating
FDA (Devices) · 2016-11-23