Recall Z-0729-2016— Philips Electronics North America Corporation

Name: FDA recall Z-0729-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-03

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-11-03, terminated 2020-09-15. It names one FDA 510(k) clearance: K002016. Product: INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions. Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-11-03
Terminated: 2020-09-15
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K002016 — PHILIPS INTEGRIS ALLURAPhilips Medical Systems North America, Inc.·cleared 2000-09-06

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

INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions

Reason for recall

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

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