Monitor Bracket Assembly Shaft Wear Risk in Philips CT Fluoroscopy Systems
Philips CT fluoroscopy monitor brackets may detach from suspension arms due to unrecognized shaft wear, risking the monitor falling and causing serious injury to patients, operators, or bystanders.
What this means for you
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 with no reported illnesses or injuries, but significant structural risk: undetected shaft wear may cause equipment detachment and monitor fall, potentially causing serious injury to patients, operators, bystanders, and service personnel. This fits the Score 3 (High) criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 1,301 Monitor Bracket Assemblies used in Continuous CT Fluoroscopy systems with ceiling-mounted monitors on Brilliance iCT models 728306 and 728311. These bracket assemblies secure the fluoroscopy monitor to the suspension arm.
The recall addresses a potential failure mechanism: significant wear of the Monitor Bracket Assembly shaft can occur without being detected by operators or maintenance personnel. This unrecognized wear may cause the bracket assembly to detach from the suspension arm, allowing the monitor to fall while remaining attached to its cables. This creates a serious hazard of injury to patients, operators, bystanders, or service personnel in the examination room.
Facilities with affected equipment should contact Philips for inspection and remediation guidance. The recall affects units distributed worldwide, including the United States, Canada, Mexico, and multiple other countries. Affected serial numbers are provided in the recall notice.
The recalled product
- Product
- Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
- 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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