The Recall Desk
HighFDA (Devices)·Z-1979-2021·Announced 2021-07-07

Philips CT Monitor Bracket Assembly risks ceiling fall hazard

Philips is recalling 1,301 Monitor Bracket Assemblies used in CT and PET/CT imaging systems worldwide due to potential shaft wear that could cause the monitor to detach from the ceiling mount and fall, posing injury risk.

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 device with identified risk of serious injury to patients and healthcare personnel from falling monitor due to mechanical wear and detachment. No injuries have been reported, so severity is limited to 3 per rubric guidelines for risk-of-harm products without reported incidents.

Plain-English summary

Philips North America LLC is recalling 1,301 Monitor Bracket Assemblies used with CT and PET/CT imaging systems (MX8000 models 728120, 728125, and 728201). The affected components have been distributed worldwide to healthcare facilities in the United States, Canada, Mexico, and over 60 other countries.

The Monitor Bracket Assembly connects to a ceiling-mounted suspension arm and holds a diagnostic display monitor. Significant wear of the monitor bracket shaft can occur and go unrecognized. If wear is not detected, the bracket assembly may detach from the suspension arm, causing the monitor to fall while remaining suspended by its cables. This presents a serious risk of injury to patients, operators, bystanders, or service personnel in the vicinity.

Affected healthcare facilities should contact Philips for guidance on inspecting affected monitor bracket assemblies for signs of wear and for available repair or replacement options.

The recalled product

Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201
Manufacturer
Philips North America Llc
Hazard
  • equipment-fall
  • mechanical-failure
  • detachment

Distribution

Distributed nationwide across the United States.