CT Monitor Bracket Assembly Recalled Due to Shaft Wear and Detachment Risk
Philips North America is recalling CT system monitor bracket assemblies due to shaft wear that could cause the bracket to detach from the suspension arm, potentially allowing the monitor to fall and cause serious injury.
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: This recall concerns a risk-of-harm product where serious injury could result from a monitor falling, but no illnesses or injuries have been reported. The hazard mechanism is specific and documented but has not resulted in reported harm to date.
Plain-English summary
Philips North America LLC is recalling 1,301 Monitor Bracket Assemblies for Continuous CT Fluoroscopy DVI ceiling-mounted imaging systems used in CT and PET/CT diagnostic facilities. The recalled components are used in Brilliance Big Bore models and function to mount and position monitors within clinical imaging settings.
The recall was initiated because significant wear of the Monitor Bracket Assembly shaft may develop without being recognized. If undetected, this wear could lead to the bracket detaching from its suspension arm. Because the monitor remains connected by electrical cables during detachment, the bracket failure could result in the monitor falling.
A falling monitor presents a serious injury risk to patients, operators, bystanders, and service personnel in healthcare environments. The 1,301 affected bracket assemblies were distributed worldwide, including throughout the United States, Canada, Mexico, and numerous other countries. Facilities with these systems should contact Philips North America LLC for instructions regarding inspection, maintenance, and replacement of affected units.
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. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore
- 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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