Recall Z-0471-2022— Philips North America Llc

Name: FDA recall Z-0471-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-12

Class II · Terminated

Class II FDA medical device recall by Philips North America Llc, initiated 2021-11-12, terminated 2024-02-05. It names one FDA 510(k) clearance: K181830. Product: Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224. Reason: (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available.

Recalling firm: Philips North America Llc
Classification: Class II
Status: Terminated
Initiated: 2021-11-12
Terminated: 2024-02-05
Firm location: Cambridge, 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

Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224

Reason for recall

(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available

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