Devices

Device Recall NeuViz Dual series computed Tomography Scanner System

Model / Serial
Serial numbers 400562, 400563, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, and NDH034EI
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
The units were distributed to one distributor in NC, and further distributed to medical facilities located in CO, FL, KY, NC, SC, TN and TX.
Product Description
NeuViz Dual series computed Tomography Scanner System, X-Ray System
Manufacturer
Philips And Neusoft Medical Systems Co., Ltd.
1 Event
- Recall of Device Recall NeuViz Dual series computed Tomography Scanner System

Manufacturer

Philips And Neusoft Medical Systems Co., Ltd.

Manufacturer Address
Philips And Neusoft Medical Systems Co., Ltd., 16 Century Road, Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning China
Source
USFDA

One device with a similar name

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Device Recall NeuViz Dual Series Computed Tomography Scanner System

Model / Serial
Part number: NeuViz Dual 989605651321. SERIAL NUMBERS: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR080031, NDHR090003, and NDHR090012.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including NC
Product Description
The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. || Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***". || Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles.
Manufacturer
Philips And Neusoft Medical Systems Co., Ltd.

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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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