Imaging device ceiling mount assembly may detach, posing injury risk
A ceiling-mounted component on Philips CT imaging equipment may detach due to wear. This poses a risk of injury to patients, operators, or staff in operating rooms.
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 involving a potential mechanical failure that could result in a falling component. Although no actual injuries have been reported, the risk of harm is significant given the operating-room setting and potential for serious injury.
Plain-English summary
Philips North America has recalled a Continuous CT Fluoroscopy system with DVI Ceiling Mount (model Gemini GXL 16 Slice, Serial Number 4165). This equipment produces real-time CT images to guide surgical procedures.
The Monitor Bracket Assembly shaft on this system may experience significant wear that goes undetected. If unrecognized, this wear could lead to the bracket assembly detaching from the suspension arm.
A ceiling-mounted component falling from the suspension arm poses a risk of injury to any person in its path—including patients, operators, bystanders, or service personnel in the operating room.
Facilities with this equipment should inspect the Monitor Bracket Assembly shaft for signs of wear and contact Philips with any questions about this recall.
The recalled product
- Product
- Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 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: 4165
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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