The Recall Desk
HighFDA (Devices)·Z-1987-2021·Announced 2021-07-07

Philips CT Monitor Bracket May Detach Due to Shaft Wear

Philips CT fluoroscopy monitors may develop bracket shaft wear that could lead to the monitor detaching and falling while attached to cables.

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 (FDA Class II) where potential for serious injury exists but no illnesses or injuries have been reported. The hazard involves structural failure of critical mounting hardware in medical imaging equipment.

Plain-English summary

Philips North America LLC is recalling Continuous CT Fluoroscopy DVI Ceiling Mount and CCT Arm DVI Option Monitor components (Model 882442 and 882456) used in Ingenuity TF PET/CT systems. These devices are used in medical facilities for diagnostic imaging.

The Monitor Bracket Assembly shaft can experience significant wear that may go unrecognized. If the wear is not detected, the monitor bracket could detach from the suspension arm, causing the monitor to fall while remaining attached to cables. This poses a potential hazard of serious injury to patients, operators, bystanders, or service personnel.

The affected equipment has been distributed worldwide, including throughout the United States and to multiple international countries.

The recalled product

Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
Manufacturer
Philips North America Llc
Category
Medical Device
Hazard
  • structural-failure
  • falling-hazard
  • equipment-wear

Distribution

Distributed nationwide across the United States.

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