Monitor Bracket Assembly Fall Hazard Recall Affects Multiple CT Systems
Philips is recalling 1,301 monitor bracket assemblies used with CT systems due to shaft wear that could cause monitors to fall, potentially injuring patients, operators, bystanders, 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: This is classified as FDA Class II. The source describes a potential hazard—unrecognized shaft wear could cause the monitor to fall, resulting in serious injury to patients, operators, bystanders, or service personnel. However, no injuries or illnesses have been reported. Per the rubric, risk-of-harm products without reported injury score High (3).
Plain-English summary
Philips North America is recalling 1,301 monitor bracket assemblies used with CT and PET/CT imaging systems. The recalled product is the Continuous CT Fluoroscopy DVI Ceiling Mount Monitor Bracket Assembly.
The recall addresses a safety issue with the bracket assembly's shaft. Significant wear of the shaft may go unrecognized, potentially causing the monitor bracket to detach from its suspension arm and the monitor to fall while remaining attached to cables.
A falling monitor could result in serious injury to patients, operators, bystanders, or service personnel. The affected units have been distributed worldwide.
The recalled product
- Product
- Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Brilliance 64 728317/728318 - Ingenuity Flex
- Manufacturer
- Philips North America Llc
- Category
- Medical Device
- Affected units
- 1,301
Distribution
Part of a larger recall action
This product is one of 12 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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