Monitor Bracket Assembly Wear May Cause Fall Hazard for Medical Imaging Equipment
Philips medical imaging equipment monitor bracket assemblies may detach due to unrecognized shaft wear, risking the monitor falling and causing serious injury to patients, operators, or bystanders.
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 imaging equipment with risk of serious injury from monitor detachment and fall. No illnesses or injuries have been reported. Per the rubric, unverified serious-injury hazards score at most 3 when no actual incidents are documented.
Plain-English summary
Philips North America is recalling 1,301 Monitor Bracket Assemblies used in Continuous CT Fluoroscopy and IQon Spectral CT imaging equipment. These assemblies mount display monitors to the equipment's ceiling suspension arm.
The bracket assembly shafts can experience significant wear over time. When this wear goes unrecognized, the assembly can detach from the suspension arm, potentially causing the monitor to fall while remaining attached to its cables.
The fall poses a serious injury risk to patients undergoing imaging procedures, operators, bystanders, and service personnel working in healthcare facilities. Affected equipment has been distributed worldwide, including throughout the United States and more than 50 other countries.
The recalled product
- Product
- Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
- 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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