The Recall Desk
HighFDA (Devices)·Z-0277-2022·Announced 2021-12-01

CT imaging system ceiling mount bracket shaft wear may cause equipment to fall

A CT fluoroscopy imaging system ceiling mount's bracket shaft may wear excessively and go undetected, potentially causing the bracket to detach and fall, risking injury to patients, operators, 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: FDA Class II recall of medical equipment with risk of serious injury from falling components. No injuries have been reported. The hazard is structural failure of a mechanical component in active medical equipment, creating potential for harm to healthcare workers and patients.

Plain-English summary

Philips is recalling a ceiling-mounted imaging system component used in continuous CT fluoroscopy-guided surgical procedures.

The Monitor Bracket Assembly shaft may experience significant wear that goes unrecognized. If undetected, this wear can lead to the bracket detaching from the Suspension Arm.

A detached bracket would fall, potentially injuring patients, operators, radiologists, bystanders, or service personnel in the path of the falling equipment.

This component was distributed to medical facilities in California, Maine, Texas, Australia, Germany, Netherlands, and Saudi Arabia.

The recalled product

Product
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
Manufacturer
Philips North America Llc
Category
Medical Device — CT Imaging System
Hazard
  • shaft-wear
  • equipment-detachment
  • falling-part

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Number: 3202

Distribution

Distributed nationwide across the United States.

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