Recall Z-1801-2020— Philips North America, LLC

Name: FDA recall Z-1801-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-05

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-03-05, terminated 2022-09-09. It names one FDA 510(k) clearance: K181830. Product: Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.. Reason: No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose...

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-03-05
Terminated: 2022-09-09
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K181830 — Azurion R2.0Philips Medical Systems Nederland B.V.·cleared 2018-08-02

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

Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.

Reason for recall

No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose..

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