Recall Z-1130-2019— Philips North America, LLC

Name: FDA recall Z-1130-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-12

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2019-03-12, terminated 2020-10-07. It names one FDA 510(k) clearance: K181830. Product: Azurion FlexArm, 722079. Reason: During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-03-12
Terminated: 2020-10-07
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

Azurion FlexArm, 722079

Reason for recall

During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.

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