Philips Medical Systems recalls
9 official recalls and safety alerts involving Philips Medical Systems since 2022-09, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Philips Medical Systems or the relevant agency.
- 2026-10-14
USPHILIPS MEDICAL SYSTEMS recalls Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333…
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
FDA · DevicePHILIPS MEDICAL SYSTEMSWorldwide - US Nationwide distribution in the states of AR, AZ, CA, CO, FL,…Official notice →- 2026-08-05
- US
PHILIPS MEDICAL SYSTEMS recalls IQon Spectral CT IQon Spectral CT Upgrades
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being…
FDA · DevicePHILIPS MEDICAL SYSTEMSUS Nationwide Distribution including Puerto RicoOfficial notice → - 2026-04-22
- US
PHILIPS MEDICAL SYSTEMS recalls Philips Spectral CT on Rails. Model Number: 728334.
Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of…
FDA · DevicePHILIPS MEDICAL SYSTEMSWorldwide - US Nationwide distribution in the states of Minnesota and the…Official notice → - 2025-11-05
- US
PHILIPS MEDICAL SYSTEMS recalls Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/…
FDA · DevicePHILIPS MEDICAL SYSTEMSDomestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT,…Official notice → - 2025-09-24
- US
Philips Medical Systems (Cleveland) Inc recalls Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code:…
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
FDA · DevicePhilips Medical Systems (Cleveland) IncU.S Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - 2025-08-13
- US
Philips Medical Systems (Cleveland) Inc recalls Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
FDA · DevicePhilips Medical Systems (Cleveland) IncWorldwide - US Nationwide distribution in the state of WV and the countries of…Official notice → - 2024-02-21
- US
PHILIPS MEDICAL SYSTEMS recalls CombiDiagnost R90 1.1 (709031)
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image…
FDA · DevicePHILIPS MEDICAL SYSTEMSUS Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME,…Official notice → - 2024-02-14
- US
PHILIPS MEDICAL SYSTEMS recalls Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
FDA · DevicePHILIPS MEDICAL SYSTEMSWorldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN,…Official notice → - 2022-09-21
- US
Philips Medical Systems (Cleveland) Inc recalls Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.
FDA · DevicePhilips Medical Systems (Cleveland) IncDistribution was made to CA, FL, GA, IA, IL, MA, MD, ME, MI, MN, NJ, NM, NV,…Official notice →