Philips CT Monitor Bracket Assembly risks ceiling fall hazard
Philips is recalling 1,301 Monitor Bracket Assemblies used in CT and PET/CT imaging systems worldwide due to potential shaft wear that could cause the monitor to detach from the ceiling mount and fall, posing injury risk.
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 for medical device with identified risk of serious injury to patients and healthcare personnel from falling monitor due to mechanical wear and detachment. No injuries have been reported, so severity is limited to 3 per rubric guidelines for risk-of-harm products without reported incidents.
Plain-English summary
Philips North America LLC is recalling 1,301 Monitor Bracket Assemblies used with CT and PET/CT imaging systems (MX8000 models 728120, 728125, and 728201). The affected components have been distributed worldwide to healthcare facilities in the United States, Canada, Mexico, and over 60 other countries.
The Monitor Bracket Assembly connects to a ceiling-mounted suspension arm and holds a diagnostic display monitor. Significant wear of the monitor bracket shaft can occur and go unrecognized. If wear is not detected, the bracket assembly may detach from the suspension arm, causing the monitor to fall while remaining suspended by its cables. This presents a serious risk of injury to patients, operators, bystanders, or service personnel in the vicinity.
Affected healthcare facilities should contact Philips for guidance on inspecting affected monitor bracket assemblies for signs of wear and for available repair or replacement options.
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: Model - MX8000 Models: 728120/728125/728201
- Manufacturer
- Philips North America Llc
- 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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