Medical Device Recall: Z-0281-2022

FDA Recalls dataset · Firm: Philips North America Llc · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2021-05-01 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0281-2022.

Recall Res Number
Z-0281-2022
Recalling Firm / Manufacturer
Philips North America Llc
FEI Number
3016618143
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2021-05-01
Date Posted
N/A
Date Terminated
N/A
Product Code
KPS
Event Number
89039
Product Quantity
4 units
Product 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.
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
Action Details Philips notified U.S. consignees by "URGENT - Field Safety Notice Medical Device Correction" FSN 72800751 for CT consignees and FSN 88200530 for PET/CT consignees via USPS Certified mail on 5/1/21. Non-U.S. customers will receive the letter through Philips Global Markets following local regulations. Letter states reason for recall, health risk and action to take: Be aware of this hazard when the safety clip is missing from the joint assembly between the Monitor Bracket Assembly and the Ceiling Suspension Arm. " Inspect the joint area of your CCT DVI Ceiling Mount Arm (the circled area in picture at the right) and observe that the safety clip is installed (as depicted in pictures below). " When this hazard occurs, the monitor may become difficult to rotate relative to the Suspension Arm. When these symptoms are recognized, in order to avoid the occurrence of a hazardous situation, take the following actions: stop using the suspension monitor clinically move the monitor arm away from any person call Philips Service for repairs. Please acknowledge the receipt of this notice by completing, signing, and returning the form to the indicated email address: CTNM.QARA@Philips.com. Philips is inspecting the affected units and, if necessary, repairing joint safety components and joint wear components by FCO 72800751 and FCO 72800752 for CT consignees, and FCO 88200530 and FCO 88200531 for AMI consignees, respectively. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
Distribution Pattern US (nationwide) distribution to states of: CA, ME, TX and OUS (Foreign) to countries of: Australia, Germany, Netherlands and Saudi Arabia.
Code Information / Serial Numbers Serial Number: 7141 7218 7229 7245

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