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    Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3

    FDA 510(k)
    FDA Class 2 ·Radiology

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEMETRON A.2

    FDA 510(k)
    FDA Class 2 ·Dental

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·January 12, 2004

    BLUNT TIP SCREW, ÿ 4X40MM

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code HSB·May 14, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 25, 2025

    BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 7, 2017

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·July 15, 2011

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 11, 2013

    TRIDENT CERAMIC ON CERAMIC HIP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MRA·September 16, 2008

    BLUNT TIP SCREW, ÿ 4X48MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·May 20, 2024

    PROXIMAL HUMERUS, RIGHT, ÿ 9X160MM

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code HSB·May 14, 2024

    PROXIMAL HUMERUS, RIGHT, LONG, ÿ 10X260MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·May 20, 2024