CLASS II Device recall · Reported 16 Jan 2019 · FDA Enforcement Report

Elekta Unity recalled

Elekta is recalling Elekta Unity, distributed in Texas, Wisconsin. The recall was initiated on 4 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 1536549, 1536549

Quantity recalled2 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0706-2019
FDA event ID: 81886
Recalling firm: Elekta, Crawley
Classification: Class II
Status: Completed
Recall initiated: 4 Jan 2019
FDA classified: 9 Jan 2019
Reported: 16 Jan 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

4 Jan 2019	Recall initiated by company
9 Jan 2019	Classified by FDA	+5 days
16 Jan 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Elekta Unity

Where it was distributed

TX and WI, Germany, Denmark, Netherlands, United Kingdom

Texas Wisconsin

Stores named: Walmart

Questions about this recall

Is Elekta Unity recalled?

Yes. Elekta recalled Elekta Unity on 4 Jan 2019. The recall is Class II and its status is Completed. Recall number Z-0706-2019.

Why was it recalled?

Which lots are affected?

Serial Numbers: 1536549, 1536549

Where was it sold?

TX and WI, Germany, Denmark, Netherlands, United Kingdom

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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