Recall Z-1984-2021— Philips North America Llc

Name: FDA recall Z-1984-2021
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: K160743. Product: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT. Reason: Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury..

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

K160743 — Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc.·cleared 2016-08-08

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 - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

Reason for recall

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

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