The Recall Desk

FDA (Devices) recall action 82937

GE Healthcare, LLC recalled 5 products on 2019-07-03

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2019-07-03
Critical
0
Units
—

Why these products were recalled

ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··2019-07-03

    GE Healthcare Recalls ECG Leadwire Sets Due to Defibrillation Risk

    GE Healthcare is recalling ECG leadwire sets because they may reduce energy reaching patients during defibrillation, potentially limiting treatment success.

    Product
    ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106389-003 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 74 cm/ 29 in 2
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-07-03

    GE Healthcare Recalls ECG Leadwire Sets Due to Defibrillation Risk

    GE Healthcare is recalling specific ECG leadwire sets because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.

    Product
    Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in 2106381-004 ECG Leadwire se
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-07-03

    GE Healthcare Recalls ECG Leadwires Due to Defibrillation Energy Reduction

    GE Healthcare is recalling 58,045 replacement ECG leadwires because they may reduce energy reaching patients during defibrillation, potentially limiting treatment success.

    Product
    Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA,
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2019-07-03

    GE Healthcare Recalls ECG Trunk Cables Due to Defibrillation Risk

    GE Healthcare is recalling ECG trunk cables that may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.

    Product
    ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2106305-004 ECG Trunk Cable, 3/5-lead, IEC, 1.2 m/4 ft.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-07-03

    GE Healthcare Recalls Replacement ECG Leadwires Due to Defibrillation Risk

    GE Healthcare is recalling 58,045 replacement ECG leadwires worldwide because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.

    Product
    Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets
    Category
    Distribution
    1 state