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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0281-2022 |
| Event ID | 89039 |
| Event 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. |
| Product Type | Devices |
| Distribution | US (nationwide) distribution to states of: CA, ME, TX and OUS (Foreign) to countries of: Australia, Germany, Netherlands and Saudi Arabia. |
| Quantity | 4 units |
| Recall Reason | 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 |
| Device Classification | 20211201 |
| Device Code Info | Serial Number: 7141 7218 7229 7245 |
| Center Classification Date | 20211123 |
| Recall Initiation Date | 20210501 |
| Recalling Firm | Philips North America Llc |
| Initial Notification | Letter |
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