Recalls / —

—#181355

Product

Elekta Unity, Image-Guided Radiation Therapy System

FDA product code

IYE — Accelerator, Linear, Medical

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K192482

Affected lot / code info

Elekta Unity Serial numbers 600014, 600016, 600017, 600018, 600019, 600020, 600021, 600022, 600023, 600024, 600025, 600026, 600027, 600028, 600029, 600030, 600031, 600032, 600033, 600034, 600035

Why it was recalled

There have been reports of excessive heating in the MRL Gradient Connection Module.

Root cause (FDA determination)

Process control

Action the firm took

Initially, the firm issued an email on 12/18/2019 to their field engineers which said they had attached a "Knowledge Article" which provided instructions on how to inspect the Philips Marlin 1.5T system used in the Elekta Unity MR Linac. On 5/11/2020, the firm issued an Urgent Important Field Safety Notification dated May, 2020, via email to consignees which explained the problem, clinical impact, and said that initial corrective actions have been performed on all impacted sites to ensure the gradient coil connection assembly is correct. It goes onto say that extensive testing of the incorrect connection material has been completed to ensure that continued use of the Elekta Unity system is acceptable, however, it remained that further actions can be taken to reduce the risk.

Recalling firm

Firm

Elekta, Inc.

Address

400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern

Distributed in US - PA, NY, and IA. Distributed ROW - Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, Netherlands, Sweden, Thailand, Turkey, UK. There was no government/military distribution.

Timeline

Recall initiated

2019-12-18

Terminated

2021-06-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #181355. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.