Elekta, Inc.: Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of m

Is my product affected?

Elekta Unity, Image-Guided Radiation Therapy System 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 w

• UPC 5060081071321

Check against the official notice below — it lists the full affected range.

What happened

The Elekta Unity Image-Guided Radiation Therapy System is being recalled due to a software issue affecting quality assurance procedures. The QA software used to check the alignment between MR and MV imaging does not display the stored offset values, preventing users from independently inspecting these values during their quality assurance checks. A total of 12 units have been distributed across Texas and Wisconsin in the United States, as well as internationally to Canada, Denmark, Germany, Italy, the Netherlands, Sweden, and the United Kingdom.

The source document does not specify a remedy or corrective action that affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.

Details from the source

Reason for recall: The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA. Distribution: US Distribution to states of: TX & WI, and Internationally to: Canada, Denmark, Germany, Italy, Netherlands, Sweden, and the UK. Quantity: 12 units Lot/code info: UDI/GTIN: 5060081071321 Installed product: UNITY SYSTEM/13553-006/600003 UNITY SYSTEM/10817-011/600010 UNITY SYSTEM/12473-020/600020 UNITY SYSTEM/12274-017/600012 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/10157-006/600014 UNITY SYSTEM/11611-40/600011 UNITY SYSTEM/11489-21/600009

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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