IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace
FDA device recall Z-0473-2015 · posted 2014-12-01 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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 .
- Action taken
- Consignees were notified of the Field Safety Notice via certified mail.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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 V
- Date initiated
- 2014-11-09
- Date posted
- 2014-12-01
- Date terminated
- 2015-09-14
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION (K132524) | Philips Medical Systems | 2014-06-13 |