The Recall Desk
HighFDA (Devices)·Z-0281-2022·Announced 2021-12-01

Continuous CT Fluoroscopy Ceiling Mount Bracket Assembly Wear Recall

Monitor bracket assemblies in Philips Continuous CT Fluoroscopy systems may experience significant wear and detach, potentially injuring patients, operators, or bystanders during surgical procedures.

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 Class II medical device recall involves a structural defect (bracket assembly wear) in surgical imaging equipment that poses a significant risk of harm to patients and medical personnel through falling parts. Although no injuries have been reported, the potential for serious injury in a surgical environment where the bracket could strike patients or staff justifies a High severity rating.

Plain-English summary

Philips North America LLC is recalling four units of the Continuous CT Fluoroscopy DVI Ceiling Mount (Gemini TF 64 System) due to a mechanical defect in the Monitor Bracket Assembly.

The Monitor Bracket Assembly shaft may experience significant wear that can go unrecognized. This wear may lead to the bracket detaching from the Suspension Arm. A detached monitor bracket could fall and injure patients, healthcare workers, bystanders, or service personnel working in the surgical area.

The affected units are identified by serial numbers 7141, 7218, 7229, and 7245. They have been distributed in the United States to facilities in California, Maine, and Texas, as well as internationally to Australia, Germany, the Netherlands, and Saudi Arabia.

Healthcare facilities and users of these systems should visually inspect the Monitor Bracket Assembly for signs of wear. If wear is detected, the system should not be used until the assembly is replaced. Contact Philips North America LLC for repair or replacement instructions.

The recalled product

Product
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 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 — Image-Guided Surgery System
Hazard
  • mechanical-failure
  • falling-part
  • injury-risk

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: 7141 7218 7229 7245

Distribution

Distributed nationwide across the United States.

Related recalls

Same category