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.
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 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
- Affected units
- 4
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
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 · mechanical failure
See all →- HighBYD Recalls 2023-2024 Ride Type A School Buses for Lift Defect
NHTSA · 2026-10-22
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- HighBaxter Recalls Likorall Overhead Lifts Due to Motor Shaft Breakage Risk
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Kits With Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
Similar recalls
- 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
- HighPhilips CT Monitor Bracket Assembly risks ceiling fall hazard
FDA (Devices) · 2021-07-07
- 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 Medical Monitor Bracket May Detach from Ceiling Mount
FDA (Devices) · 2021-07-07