Recall Z-0473-2015— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0473-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-09

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2014-11-09, terminated 2015-09-14. It names one FDA 510(k) clearance: K132524. Product: IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed. Reason: Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (THV) to be implanted ..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2014-11-09
Terminated: 2015-09-14
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K132524 — CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATIONPhilips Medical Systems·cleared 2014-06-13

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

IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed

Reason for recall

Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (THV) to be implanted .

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