BEUDAMED
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    Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code IYE·December 14, 2025

    Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code HGP·November 21, 2022

    The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.

    FDA Recall
    Open, Classified ·Ge Healthcare·Product code RCC·May 8, 2020

    Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·January 6, 2022

    Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·January 6, 2022

    Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·January 6, 2022

    Molding Equipment. WCM series. Model WCM-330GL-i

    FDA Recall
    Open, Classified ·Apic Yamada America·Product code RHK·April 7, 2025

    (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)

    FDA Recall
    Open, Classified ·Philips North America·Product code LNI·July 15, 2021

    Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

    FDA Recall
    Open, Classified ·Philips North America·Product code JAA·October 27, 2025

    Philips Incisive CT

    FDA Recall
    Open, Classified ·Philips Healthcare (Suzhou) Co., Ltd. Suzhou Industrial Park No.·Product code JAK·December 3, 2025

    Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Eleva with Flat Detector.

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code IZI·May 18, 2026

    Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025