Reported Jan 16, 2019 · Completed

Elekta Unity

Elekta Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Elekta Limited · Linac House · Crawley · N/A

Is this the product you have?

  • Elekta Unity
Lot codes and dates
  • Serial Numbers
    • 1536549
    • 1536549
Amount recalled
2 units

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.