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Philips North America Llc Recall 89039

Description: Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

Philips North America Llc Recall 89039 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0281-2022
Event ID89039
Event DescriptionContinuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
Product TypeDevices
DistributionUS (nationwide) distribution to states of: CA, ME, TX and OUS (Foreign) to countries of: Australia, Germany, Netherlands and Saudi Arabia.
Quantity4 units
Recall ReasonSignificant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part
Device Classification20211201
Device Code InfoSerial Number: 7141 7218 7229 7245
Center Classification Date20211123
Recall Initiation Date20210501
Recalling FirmPhilips North America Llc
Initial Notification Letter
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