Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 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.
Reported: December 1, 2021 Initiated: May 1, 2021 #Z-0279-2022
Product Description
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 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.
Reason for Recall
Significant 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
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 1 unit
- Distribution
- US (nationwide) distribution to states of: CA, ME, TX and OUS (Foreign) to countries of: Australia, Germany, Netherlands and Saudi Arabia.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 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.. Recalled by Philips North America Llc. Units affected: 1 unit.
Why was this product recalled? ▼
Significant 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 1, 2021. Severity: Moderate. Recall number: Z-0279-2022.
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