Device Recall Signa Ovation

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Radiology Devices

2

No

Worldwide Distribution -- USA, including states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, KS, KY, LA, MD, MA, MI, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WV, and WI and countries of VENEZUELA, ECUADOR, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, SPAIN, RUSSIAN FEDERATION, REPUBLIC OF KOREA, POLAND, PHILIPPINE,S OMAN, MEXICO, KUWAIT, JAPAN, ITALY, HUNGARY, GERMANY, EGYPT, DENMARK, CHILE, CHINA, and BRASIL.

Signa Ovation, 0.35T MR Systems (MFO 1-4). || Indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the musculoskeletal, vascular, cardiac, and neuro systems.