Philips CT Scanner Recall Due to Inaccurate Extended Display Reconstruction
Philips Medical Systems is recalling 61 CT scanners because the Extended Display Field of View reconstruction feature produces inaccurate CT numbers and anatomy.
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. The hazard involves inaccurate diagnostic imaging data, which poses a risk of harm through misdiagnosis, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 61 computed tomography (CT) scanners, specifically Model 728243 with software versions 2.2.1 and 2.2.2. The recall is due to a software defect where the Extended Display Field of View reconstruction feature displays inaccurate CT numbers and anatomy in the extended region.
The affected devices were distributed worldwide, including in the United States (MO, TX, MD, AR, VA, KY, RI, NJ, MA, NY, LA, PA, VT, SC, CA, OH, FL, MN, MI) and internationally to the Netherlands, Canada, Finland, Austria, France, Malaysia, Denmark, Norway, UK, Australia, and Belgium. The devices are intended to provide cross-sectional images of the human body and visualization of internal organs.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. The FDA has classified this as a Class II recall, indicating that use of the device may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 61
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 (1)
- Model 728243 Software version 2.2.1 and 2.2.2
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 · inaccurate data
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighPhilips Recalls Cardiac Workstation 5000 Units for Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
- HighPhilips Recalls Cardiac Workstation 7000 Due to Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
- HighICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issues
FDA (Devices) · 2020-05-06
- ModerateRandox Chemistry QC Premium Plus Recalled for Incorrect Sodium Values
FDA (Devices) · 2020-04-01
Similar recalls
- ModeratePhilips Brilliance 16 CT Scanner Recalled for Image Reconstruction Defect
FDA (Devices) · 2016-08-31
- ModeratePhilips Brilliance 64 CT Scanner Recalled for Image Reconstruction Errors
FDA (Devices) · 2016-08-31
- HighPhilips Incisive CT Scanner Software Issues May Cause Misdiagnosis
FDA (Devices) · 2024-01-17
- ModeratePhilips Brilliance BigBore CT Scanner Recalled for Image Reconstruction Error
FDA (Devices) · 2016-08-31
- ModeratePhilips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Failure
FDA (Devices) · 2017-10-25
- HighPhilips Brilliance 64 CT System Recalled for Software Defects
FDA (Devices) · 2015-12-16