Recall Z-0278-2022— Philips North America Llc

Name: FDA recall Z-0278-2022
Creator: U.S. Food and Drug Administration
Published: 2021-05-01

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2021-05-01. It names one FDA 510(k) clearance: K051170. Product: Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 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: 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.

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2021-05-01
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K051170 — GEMINI GXLPhilips Medical Systems (Cleveland), Inc.·cleared 2005-05-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.