The Recall Desk
HighFDA (Devices)·Z-1982-2021·Announced 2021-07-07

Monitor Bracket Assembly Fall Hazard Recall Affects Multiple CT Systems

Philips is recalling 1,301 monitor bracket assemblies used with CT systems due to shaft wear that could cause monitors to fall, potentially injuring patients, operators, bystanders, or service personnel.

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 classified as FDA Class II. The source describes a potential hazard—unrecognized shaft wear could cause the monitor to fall, resulting in serious injury to patients, operators, bystanders, or service personnel. However, no injuries or illnesses have been reported. Per the rubric, risk-of-harm products without reported injury score High (3).

Plain-English summary

Philips North America is recalling 1,301 monitor bracket assemblies used with CT and PET/CT imaging systems. The recalled product is the Continuous CT Fluoroscopy DVI Ceiling Mount Monitor Bracket Assembly.

The recall addresses a safety issue with the bracket assembly's shaft. Significant wear of the shaft may go unrecognized, potentially causing the monitor bracket to detach from its suspension arm and the monitor to fall while remaining attached to cables.

A falling monitor could result in serious injury to patients, operators, bystanders, or service personnel. The affected units have been distributed worldwide.

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. Brilliance 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Brilliance 64 728317/728318 - Ingenuity Flex
Manufacturer
Philips North America Llc
Category
Medical Device
Hazard
  • mechanical-failure
  • fall-hazard

Distribution

Distributed nationwide across the United States.

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