Recall Z-0925-2017— Philips Electronics North America Corporation

Name: FDA recall Z-0925-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-01

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2016-12-01, terminated 2017-08-10. It names one FDA 510(k) clearance: K133292. Product: Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).. Reason: Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-12-01
Terminated: 2017-08-10
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K133292 — ALLURA XPER FD; OR TABLEPhilips Medical Systems Nederland B.V.·cleared 2014-03-05

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

Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).

Reason for recall

Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.

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