The Recall Desk
HighFDA (Devices)·Z-1985-2021·Announced 2021-07-07

Monitor Bracket Assembly Wear May Cause Fall Hazard for Medical Imaging Equipment

Philips medical imaging equipment monitor bracket assemblies may detach due to unrecognized shaft wear, risking the monitor falling and causing serious injury to patients, operators, or bystanders.

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: FDA Class II recall for medical imaging equipment with risk of serious injury from monitor detachment and fall. No illnesses or injuries have been reported. Per the rubric, unverified serious-injury hazards score at most 3 when no actual incidents are documented.

Plain-English summary

Philips North America is recalling 1,301 Monitor Bracket Assemblies used in Continuous CT Fluoroscopy and IQon Spectral CT imaging equipment. These assemblies mount display monitors to the equipment's ceiling suspension arm.

The bracket assembly shafts can experience significant wear over time. When this wear goes unrecognized, the assembly can detach from the suspension arm, potentially causing the monitor to fall while remaining attached to its cables.

The fall poses a serious injury risk to patients undergoing imaging procedures, operators, bystanders, and service personnel working in healthcare facilities. Affected equipment has been distributed worldwide, including throughout the United States and more than 50 other countries.

The recalled product

Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
Manufacturer
Philips North America Llc
Category
Medical Device — Imaging Equipment Mounting
Hazard
  • bracket-wear
  • fall-hazard
  • impact-injury

Distribution

Distributed nationwide across the United States.

Related recalls

Same category