Philips CT Monitor Bracket Assembly May Detach and Fall
Philips is recalling 1,301 monitor bracket assemblies for CT imaging systems due to shaft wear that could cause detachment and fall of the monitor. This could result in serious injury to patients, operators, and staff.
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 where detachment and fall of medical imaging equipment could cause serious injury to multiple people. The FDA classified this as Class II. No illnesses or injuries have been reported; the hazard remains theoretical.
Plain-English summary
Philips North America LLC is recalling 1,301 monitor bracket assemblies used in continuous CT fluoroscopy systems, including the Ingenuity Core, Ingenuity Core 128, and Ingenuity CT models. These ceiling-mounted assemblies are distributed worldwide.
The monitor bracket assembly shaft can experience significant wear. If this wear goes unrecognized, the assembly may detach from the suspension arm.
When detachment occurs, the monitor may fall while remaining attached to cables. This poses a potential risk of serious injury to patients, operators, bystanders, and service personnel.
The recalled product
- Product
- Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
- 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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