medical Class II Updated 2021-07-07

Philips North America Llc recalls Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Op

Recalled Product

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT


Hazard / Issue

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model/ Serial Number/UDI: N/A System Code System Serial Number Unique Device Identifier (UDI#) 882442 2155 (01)00884838059443(21)2155 882442 2154 (01)00884838059443(21)2154 882442 2166 (01)00884838059443(21)2166 882442 2171 (01)00884838059443(21)2171 882442 2153 (01)00884838059443(21)2153
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