Philips Medical Systems (Cleveland) Inc: 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: 881

Is my product affected?

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

• UPC 45001985333

Check against the official notice below — it lists the full affected range.

What happened

Philips Medical Systems is recalling 32 IntelliSpace Portal software systems used to measure heart and aortic anatomy for selecting and sizing transcatheter heart valves. The software contains a defect that may cause the application to display incorrect measurements in certain circumstances. The affected systems were distributed worldwide, including in the United States in Florida, North Carolina, and Vermont, as well as in Argentina, Austria, Belgium, Canada, Denmark, France, India, Italy, Japan, the Netherlands, the United Kingdom, and Vietnam.

The recall affects specific lot and code numbers across multiple IntelliSpace Portal models and variants. According to the recall record, no remedy information is specified.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 .

Details from the source

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 . 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. Quantity: 32 Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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