Philips CT Monitor Bracket May Detach Due to Shaft Wear
Philips CT fluoroscopy monitors may develop bracket shaft wear that could lead to the monitor detaching and falling while attached to cables.
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 a risk-of-harm product (FDA Class II) where potential for serious injury exists but no illnesses or injuries have been reported. The hazard involves structural failure of critical mounting hardware in medical imaging equipment.
Plain-English summary
Philips North America LLC is recalling Continuous CT Fluoroscopy DVI Ceiling Mount and CCT Arm DVI Option Monitor components (Model 882442 and 882456) used in Ingenuity TF PET/CT systems. These devices are used in medical facilities for diagnostic imaging.
The Monitor Bracket Assembly shaft can experience significant wear that may go unrecognized. If the wear is not detected, the monitor bracket could detach from the suspension arm, causing the monitor to fall while remaining attached to cables. This poses a potential hazard of serious injury to patients, operators, bystanders, or service personnel.
The affected equipment has been distributed worldwide, including throughout the United States and to multiple international countries.
The recalled product
- Product
- Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
- Manufacturer
- Philips North America Llc
- Category
- Medical Device
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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