Devices

Device Recall ISP DX/HX/EX, ISP DX/HX/EX Upgrade, ISP DX/HX/EX Demo, ISP IX

Model / Serial
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
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
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 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
Manufacturer
Philips Medical Systems (Cleveland) Inc
1 Event
- Recall of Device Recall ISP DX/HX/EX, ISP DX/HX/EX Upgrade, ISP DX/HX/EX Demo, ISP IX

Manufacturer

Philips Medical Systems (Cleveland) Inc

Manufacturer Address
Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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