BEUDAMED
    41 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Status: Ongoing × Clear all

    Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Ear Sensor, REF TS-E-D; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Wrap Sensor, REF TS-W-D; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025

    GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025

    GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025