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

26–27 of 27

  • HighFDA (Devices)··2018-10-03

    Philips INTEGRIS Allura 9 F FDXD Monitor Suspension Recall

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

    Product
    INTEGRIS Allura 9 F FDXD, System Code 722497 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 Ceiling Monitor Suspension Recall

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

    Product
    Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Distribution
    51 states