—#173856

Product

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 with a defined treatment plan.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K182076
Affected 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

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

The firm, Elekta, disseminated their "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" by email on 06/24/2019 to its customers. The notices identified the problem, provided recommended actions, and requested the notice be placed in a place accessible to all users. Customers were also instructed to complete and return the Acknowledgement Form. A software update will be provided once available. If you have any questions, contact the Post Market Surveillance Specialist by email: Elekta_Global_PMS@elekta.com.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: US Distribution to states of: TX & WI, and Internationally to: Canada, Denmark, Germany, Italy, Netherlands, Sweden, and the UK.

Timeline

Recall initiated: 2019-06-24
Posted by FDA: 2019-07-16
Terminated: 2021-04-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173856. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.