Devices

Device Recall Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system

Model / Serial
Site Numbers: 6931, 6934, 25834, 25901, 26140, 38086, 38195, 38196, 38279, 38500, 38539, 41111, 44282, 44656, 44657, 45070, 50230, 64158, 73286, 80306, 82503, 82630, 82646, 84939, 86395, 100727, 101142, 101555, 102034, 102169, 102590, 102591, 103421, 104104, 104810, 520185, 557985, 558101, and 558174.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution: USA including states of: AZ, CA, CO, CT, DE, FL, GA, HI, ID, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, and WY.
Product Description
Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system. || The Philips EasyDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/universal system, general R/F, Fluoroscopy, Radiography, and Angiography can be performed along with pediatric examinations and some more specialized interventional applications.
Manufacturer
Philips Medical Systems North America Co. Phillips
1 Event
- Recall of Device Recall Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 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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