Agency classClass IIOur severity:High FDA (Devices)·Z-0280-2022·Announced 2021-12-01

Philips CT Fluoroscopy Ceiling Mount Bracket Wear and Detachment Hazard

Philips Continuous CT Fluoroscopy ceiling mounts may experience monitor bracket assembly wear that goes undetected, potentially causing the bracket to detach and fall on patients, operators, or bystanders during surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 a risk-of-harm product with a structural failure hazard in a medical surgical setting where consequences could be serious, but no illnesses, injuries, or deaths have been reported. It meets the Score 3 criterion of a risk-of-harm product where injury has not yet been reported.

Plain-English summary

This recall involves the Continuous CT Fluoroscopy DVI Ceiling Mount with Monitor Bracket Assembly, part of the Gemini TF 16 System (Model 882470), manufactured by Philips North America LLC. The ceiling-mounted device is used in image-guided surgery to produce real-time CT images for physicians and radiologists.

The Monitor Bracket Assembly shaft may experience significant wear that goes undetected during routine inspection. If this wear is not recognized, the bracket assembly can detach from the ceiling-mounted suspension arm, causing the component to fall. A falling part poses a risk of injury to anyone in its path, including patients, operators, bystanders, and service personnel.

The recall affects three units identified by serial numbers 7084, 7145, and 7584. These have been distributed in the United States (California, Maine, Texas) and internationally (Australia, Germany, Netherlands, Saudi Arabia).

The recalled product

Product: Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 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
Hazard: mechanical-failure
falling-object
impact-injury
Affected units: 3

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: 7084 7145 7584

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Philips North America Llc

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