Recall Z-1140-2019— Philips Medical Systems Nederlands

Name: FDA recall Z-1140-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-19

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems Nederlands, initiated 2019-02-19, terminated 2020-10-14. It names 5 FDA 510(k) clearances: K050151, K041949, K033737 and 2 more. Product: Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.. Reason: Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures..

Recalling firm: Philips Medical Systems Nederlands
Classification: Class II
Status: Terminated
Initiated: 2019-02-19
Terminated: 2020-10-14
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

5 on FDA's record

K050151 — MULTIDIAGNOST ELEVAPhilips Medical Systems North America, Inc.·cleared 2005-02-09
K041949 — ALLURA XPER FD10Philips Medical Systems North America Co.·cleared 2004-07-30
K033737 — ALLURA XPER FD20Philips Medical Systems North America, Inc.·cleared 2003-12-09
K031333 — PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2Philips Medical Systems North America, Inc.·cleared 2003-05-13
K984545 — RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMSPhilips Medical Systems North America, Inc.·cleared 1999-02-25

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

Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.

Reason for recall

Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.

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