The Recall Desk
HighFDA (Devices)·Z-0279-2022·Announced 2021-12-01

PET/CT Imaging System Ceiling Mount May Detach Due to Bracket Wear

Philips TruFlight Select PET/CT imaging systems have a Monitor Bracket Assembly that may detach from the ceiling mount due to undetected shaft wear, posing a risk of injury to patients, staff, and bystanders.

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 an FDA Class II medical device recall with no reported injuries or illnesses. The hazard involves potential equipment detachment and falling objects, but per the rubric, risk-of-harm products without reported injury score as High (3).

Plain-English summary

Philips North America LLC is recalling the Monitor Bracket Assembly component of its TruFlight Select PET/CT imaging system (Serial Number 17006). This assembly holds the imaging monitor during continuous CT fluoroscopy procedures that support image-guided surgery.

The shaft of the Monitor Bracket Assembly can develop significant wear that may not be visually apparent during routine observation. This unrecognized wear can cause the assembly to detach from the Suspension Arm.

If detachment occurs, the falling component poses a risk of injury to patients, surgical staff, bystanders, or service personnel located beneath or near the device. The affected unit with Serial Number 17006 has been distributed to medical facilities in California, Maine, Texas, Australia, Germany, the Netherlands, and Saudi Arabia.

The recalled product

Product
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 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/PET System Component
Hazard
Affected units
1

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: 17006

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 →

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