Devices

Device Recall MultiDiagnost Eleva with Flat Detector (MDE FD)

Model / Serial
software version 4.3.1 or higher. Units are identified with Site Numbers: 538440, 542581, 543228, 543846, 543886, 544123, 544124, 544904, 545113, 545114, 548112, 551714, 553435, 553838, 554283, 554284, 554633, 554640, 556369, 557258, 41445127, 41445131, 41445800, 41455927, 41643223, 41849575, 42549980, 42799914, and 41445927.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution including states CA, CO, IA, ID, KS, MN, NC, NJ, NY, OH, SC, TX, UT, VA, and WI.
Product Description
Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher || Used for general R/F, fluoroscopy, radiography, and angiography examinations.
Manufacturer
Philips Medical Systems North America Co. Phillips
1 Event
- Recall of Device Recall MultiDiagnost Eleva with Flat Detector (MDE FD)

Manufacturer

Philips Medical Systems North America Co. Phillips

Manufacturer Address
Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
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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