FDAClass IIJanuary 16, 2019

Elekta Unity recall

Elekta Unity

Why was Elekta Unity recalled?

In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: 1536549, 1536549

Product
Elekta Unity
Recalling firm
Elekta Limited
Quantity
2 units
Distribution
TX and WI, Germany, Denmark, Netherlands, United Kingdom
Recall date
January 16, 2019
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls