The Recall Desk

FDA (Devices) recall action 80922

Philips Electronics North America Corporation recalled 27 products on 2018-10-03

The FDA (Devices) publishes a recall like this one as 27 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 27 pages.

Products
27
Announced
2018-10-03
Critical
0
Units
138,105

Why these products were recalled

There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 27

  • HighFDA (Devices)··2018-10-03

    Philips AlIura Xper F010 F Monitor Ceiling Suspension Recall

    Philips is recalling AlIura Xper F010 F systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips Allura Xper FD2O Ceiling Monitor Suspension Recall

    Philips is recalling 5,115 Allura Xper FD2O systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips INTEGRIS CV Ceiling Monitor Suspension Recall for Detachment Risk

    Philips is recalling INTEGRIS CV systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips Medical Monitor Ceiling Suspension Recall for Detachment Risk

    Philips is recalling 5,115 medical monitor ceiling suspensions because the monitor may detach from the actuator, posing a risk of injury to patients and users.

    Product
    Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips Allura Xper FD2O Biplane Recall for Monitor Suspension Defect

    Philips is recalling 5,115 Allura Xper FD2O Biplane systems because the monitor ceiling suspension may detach, causing the monitor to fall and risk injury.

    Product
    Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips Allura Xper FD2O Biplane Recall for Monitor Suspension Detachment Risk

    Philips is recalling 5,115 Allura Xper FD2O Biplane systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips INTEGRIS Allura 15-12 Biplane Monitor Suspension Recall

    Philips is recalling INTEGRIS Allura 15-12 biplane systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips AIIura Xper F010 DR Table Recall for Monitor Detachment Risk

    Philips is recalling AIIura Xper F010 DR Tables because the ceiling monitor suspension may detach, posing a risk of injury to patients and staff.

    Product
    AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips FlexVision Monitor Ceiling Suspension Recall for Detachment Risk

    Philips is recalling FlexVision Monitor Ceiling Suspensions because the monitor may detach from the actuator rotor shaft, posing a risk of injury to patients, users, and bystanders.

    Product
    AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips INTEGRIS Allura Monitor Ceiling Suspension Recall for Detachment Risk

    Philips is recalling INTEGRIS Allura 15-12 systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips INTEGRIS Allura 9 Biplane Recall for Monitor Suspension Defect

    Philips is recalling INTEGRIS Allura 9 biplane systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips Allura Xper F020 Biplane DR Table Recall for Monitor Suspension Defect

    Philips is recalling 5,115 Allura Xper F020 Biplane DR Tables because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips Allura Xper F010 DR Table Recall for Monitor Detachment Risk

    Philips is recalling 5,115 Allura Xper F010 DR Tables because the ceiling monitor suspension may detach, posing a risk of injury from falling equipment.

    Product
    Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips Allura Xper F020 DR Table Recall for Monitor Suspension Defect

    Philips is recalling 5,115 Allura Xper F020 DR Tables because the ceiling monitor suspension may detach, posing a risk of injury from falling equipment.

    Product
    Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips Medical Monitor Ceiling Suspension Recall Due to Detachment Risk

    Philips is recalling 5,115 medical monitor ceiling suspensions because the monitor may detach and fall, posing an injury risk to patients and users.

    Product
    Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips NTEGRIS Allura 9 0 FDXD Ceiling Monitor Recall

    Philips is recalling NTEGRIS Allura 9 0 FDXD systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips INTEGRIS SUITE Ceiling Monitor Suspension Recall

    Philips is recalling INTEGRIS SUITE systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients or users.

    Product
    INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips FlexVision Monitor Ceiling Suspension Recall Due to Detachment Risk

    Philips is recalling FlexVision Monitor Ceiling Suspensions because the monitor may detach from the actuator rotor shaft, posing a risk of injury to patients, users, and bystanders.

    Product
    AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips Allura Xper FD1O C Ceiling Monitor Recall for Detachment Risk

    Philips is recalling 5,115 Allura Xper FD1O C systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips INTEGRIS Allura 9 Monitor Ceiling Suspension Recall

    Philips is recalling INTEGRIS Allura 9 systems because the monitor ceiling suspension may detach, causing the monitor to fall and risk injury.

    Product
    INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips AlluraXperFOlO/lO Ceiling Monitor Suspension Recall

    Philips is recalling 5,115 AlluraXperFOlO/lO systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients or users.

    Product
    AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips Allura Xper F010/10 DRTable Recall for Monitor Suspension Defect

    Philips is recalling 5,115 Allura Xper F010/10 DRTables because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips Medical Monitor Ceiling Suspension Recall Due to Detachment Risk

    Philips is recalling 5,115 medical monitor ceiling suspensions because the monitor may detach from the actuator rotor shaft and fall, posing a risk of injury to patients, users, and bystanders.

    Product
    Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips Allura Xper FD2O Monitor Ceiling Suspension Recall

    Philips is recalling Allura Xper FD2O systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2018-10-03

    Philips Allura Xper F020 DR Table Recall for Monitor Suspension Defect

    Philips is recalling 5,115 Allura Xper F020 DR Tables because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states