The Recall Desk
HighFDA (Devices)·Z-1984-2021·Announced 2021-07-07

Philips CT Monitor Bracket Assembly May Detach and Fall

Philips is recalling 1,301 monitor bracket assemblies for CT imaging systems due to shaft wear that could cause detachment and fall of the monitor. This could result in serious injury to patients, operators, and staff.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product where detachment and fall of medical imaging equipment could cause serious injury to multiple people. The FDA classified this as Class II. No illnesses or injuries have been reported; the hazard remains theoretical.

Plain-English summary

Philips North America LLC is recalling 1,301 monitor bracket assemblies used in continuous CT fluoroscopy systems, including the Ingenuity Core, Ingenuity Core 128, and Ingenuity CT models. These ceiling-mounted assemblies are distributed worldwide.

The monitor bracket assembly shaft can experience significant wear. If this wear goes unrecognized, the assembly may detach from the suspension arm.

When detachment occurs, the monitor may fall while remaining attached to cables. This poses a potential risk of serious injury to patients, operators, bystanders, and service personnel.

The recalled product

Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
Manufacturer
Philips North America Llc
Hazard
  • mechanical-wear
  • equipment-fall
  • impact-injury

Distribution

Distributed nationwide across the United States.