Devices

Essenta DR Xray system

Model / Serial
Devices were identified as SITE numbers: 553491, 554498, 554944, 553270, 554358, 556089, 556275, 555457, 556080, 557203, 41446107, 41446304, 41443692, 41446097, 41445359, 41445529, 41585399, 41586528, 41796147, 41958550, 42252302, 42616819, and 42865052.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution: CA, GA, FL, KS, MN, NY, OH, OR, SC, TN, TX, UT, and WA.
Product Description
Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography. || It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile X-ray table (trolley). || The intended use is from direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.
Manufacturer
Philips Medical Systems North America Co. Phillips
1 Event
- Recall of Essenta DR Xray system

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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