Philips IntelliSpace Portal Software Defect May Display Incorrect Cardiac Measurements
Philips is recalling 32 IntelliSpace Portal systems due to a software defect that may display incorrect cardiac and aortic anatomy measurements used for sizing Transcatheter heart valves.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a software defect in a medical device that may lead to incorrect sizing of a heart valve, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 32 units of IntelliSpace Portal DX/HX/EX and IX systems due to a software defect. The affected model numbers are 881001, 881011, 881012, and 881030.
The defect may cause the application to display incorrect measurements of cardiac and aortic anatomy in certain circumstances. These measurements are used to select and size the Transcatheter heart valve (THV) to be implanted.
The recall covers units distributed worldwide, including in the United States (Florida, North Carolina, and Vermont) and in Argentina, Austria, Belgium, Canada, Denmark, France, India, Italy, Japan, Netherlands, United Kingdom, and Vietnam. Users should contact Philips Medical Systems for further instructions regarding the software defect.
The recalled product
- 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
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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