medical Class II Updated 2019-05-15

Elekta Limited recalls Elekta Unity systems Product Usage: Elekta Unity using M

Recalled Product

Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

Hazard / Issue

There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Product Code: UNITY SYSTEM/13553-006/600003, UNITY SYSTEM/10817-011/600010, UNITY SYSTEM/10562-011/600016; UNITY SYSTEM/10719-T03001/600013, UNITY SYSTEM/30004070-001/600023, UNITY SYSTEM/10420-AVL-U/600008, UNITY SYSTEM/11014-UMCU-U/600007, UNITY SYSTEM/11611-40/600011, UNITY SYSTEM/11489-21/600009; UDI: 1536549, 1536549

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