Recall Z-1066-2016— Philips Electronics North America Corporation

Name: FDA recall Z-1066-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-01

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-10-01, terminated 2020-10-08. It names one FDA 510(k) clearance: K141979. Product: Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology (EP). The Allura Xper FD2O, Allura Xper FD2O/10 and Allura Xper FD2O/20 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures.. Reason: Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-10-01
Terminated: 2020-10-08
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K141979 — ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIESPhilips Medical Systems Netherland BV·cleared 2014-08-19

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 X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology (EP). The Allura Xper FD2O, Allura Xper FD2O/10 and Allura Xper FD2O/20 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures.

Reason for recall

Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.

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