The Recall Desk

FDA (Devices) recall action 89039

Philips North America Llc recalled 5 products on 2021-12-01

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
2021-12-01
Critical
0
Units
10

Why these products were recalled

Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part

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

1–5 of 5

  • HighFDA (Devices)··2021-12-01

    CT imaging system ceiling mount bracket shaft wear may cause equipment to fall

    A CT fluoroscopy imaging system ceiling mount's bracket shaft may wear excessively and go undetected, potentially causing the bracket to detach and fall, risking injury to patients, operators, or service personnel.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2021-12-01

    Continuous CT Fluoroscopy Ceiling Mount Bracket Assembly Wear Recall

    Monitor bracket assemblies in Philips Continuous CT Fluoroscopy systems may experience significant wear and detach, potentially injuring patients, operators, or bystanders during surgical procedures.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2021-12-01

    Philips CT Fluoroscopy Ceiling Mount Bracket Wear and Detachment Hazard

    Philips Continuous CT Fluoroscopy ceiling mounts may experience monitor bracket assembly wear that goes undetected, potentially causing the bracket to detach and fall on patients, operators, or bystanders during surgery.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2021-12-01

    Imaging device ceiling mount assembly may detach, posing injury risk

    A ceiling-mounted component on Philips CT imaging equipment may detach due to wear. This poses a risk of injury to patients, operators, or staff in operating rooms.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2021-12-01

    PET/CT Imaging System Ceiling Mount May Detach Due to Bracket Wear

    Philips TruFlight Select PET/CT imaging systems have a Monitor Bracket Assembly that may detach from the ceiling mount due to undetected shaft wear, posing a risk of injury to patients, staff, and bystanders.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
    Category
    Distribution
    3 states