Z-0473-2015Class II

IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011...

Name: Z-0473-2015 IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2014-11-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-11-09 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of 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... on 2014-11-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0473-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-09
Posted: 2014-12-01
Terminated: 2015-09-14
Recalling firm: Philips North America LLC
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
Product code: JAK 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 .
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified of the Field Safety Notice via certified mail.
Quantity in commerce: 32
Distribution: Worldwide Distribution: US Distribution in states of: FL, NC, and VT; and the countries of Argentina, Austria, Belgium, Canada, Denmark, France, India, Italy, Japan, Netherlands, United Kingdom, and Vietnam.
Product codes and lots: IntelliSpace Portal DX/HX/EX: 96027,96029,96025,96030,96031,85479,79935, 98087,85175,96024,106013,450003, 950002, 950003,35009,35030,870056, 550012, 85081, 97069, 45001985333, 35036, and 85382. IntelliSpace Portal DX/HX/EX Upgrade: 950100, 55003, and 81178. IntelliSpace Portal DX/HX/EX Demo: 85451 and 87290. IntelliSpace Portal IX: 50306, 40219, and 40368. 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0473-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0473-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-26

Product code JAK

K132524Class IICT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems / cleared 2014-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)