Recall Z-0348-2016— Philips Medical Systems, Inc.

Name: FDA recall Z-0348-2016
Creator: U.S. Food and Drug Administration
Published: 2015-02-03

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2015-02-03, terminated 2017-01-18. It names 4 FDA 510(k) clearances: K130842, K041949, K033737 and 1 more. Product: Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures. Reason: Monitor Ceiling Suspension system may fall.

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-02-03
Terminated: 2017-01-18
Firm location: Andover, MA, United States

510(k) clearances named in this recall

4 on FDA's record

K130842 — ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIESPhilips Medical Systems Nederland B.V.·cleared 2013-05-21
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
K971365 — PHILIPS INTEGRIS H5000Philips Medical Systems North America, Inc.·cleared 1997-05-14

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 Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures

Reason for recall

Monitor Ceiling Suspension system may fall

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