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.
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 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
- 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
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 →Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Same hazard · equipment wear
See all →- HighPhilips CT Monitor Bracket May Detach Due to Shaft Wear
FDA (Devices) · 2021-07-07
Similar recalls
- HighPhilips Monitor Bracket Assembly falls due to shaft wear in medical imaging systems
FDA (Devices) · 2021-07-07
- HighPhilips CT Monitor Bracket May Detach Due to Shaft Wear
FDA (Devices) · 2021-07-07
- HighPhilips CT Monitor Bracket Assembly risks ceiling fall hazard
FDA (Devices) · 2021-07-07
- HighMonitor Bracket Assembly Wear May Cause Fall Hazard for Medical Imaging Equipment
FDA (Devices) · 2021-07-07
- HighPhilips Continuous CT Fluoroscopy Monitor Bracket Assembly Fall Risk
FDA (Devices) · 2021-07-07
- HighPhilips CT Monitor Bracket Assemblies Recalled for Detachment Risk
FDA (Devices) · 2021-07-07