CT imaging system ceiling mount bracket shaft wear may cause equipment to fall
A CT fluoroscopy imaging system ceiling mount's bracket shaft may wear excessively and go undetected, potentially causing the bracket to detach and fall, risking injury to patients, operators, or service personnel.
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: FDA Class II recall of medical equipment with risk of serious injury from falling components. No injuries have been reported. The hazard is structural failure of a mechanical component in active medical equipment, creating potential for harm to healthcare workers and patients.
Plain-English summary
Philips is recalling a ceiling-mounted imaging system component used in continuous CT fluoroscopy-guided surgical procedures.
The Monitor Bracket Assembly shaft may experience significant wear that goes unrecognized. If undetected, this wear can lead to the bracket detaching from the Suspension Arm.
A detached bracket would fall, potentially injuring patients, operators, radiologists, bystanders, or service personnel in the path of the falling equipment.
This component was distributed to medical facilities in California, Maine, Texas, Australia, Germany, Netherlands, and Saudi Arabia.
The recalled product
- Product
- Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 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: 3202
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.
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Same hazard · shaft wear
See all →- HighMonitor Bracket Assembly Shaft Wear Risk in Philips CT Fluoroscopy Systems
FDA (Devices) · 2021-07-07
- HighPhilips Monitor Bracket Assembly falls due to shaft wear in medical imaging systems
FDA (Devices) · 2021-07-07
- HighMonitor bracket assembly recalled for detachment hazard on CT imaging systems
FDA (Devices) · 2021-07-07
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