Z-0706-2019Class II

Elekta Unity

Name: Z-0706-2019 Elekta Unity
Creator: Elekta Limited
Published: 2019-01-04
License: https://open.fda.gov/license/

Elekta Limited / initiated 2019-01-04 / Completed

FDA source

Elekta Limited began a recall of Elekta Unity on 2019-01-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0706-2019
Classification: Class II
Status: Completed
Initiated: 2019-01-04
Posted: 2019-01-09
Recalling firm: Elekta Limited
Product: Elekta Unity
Product code: IYE Accelerator, Linear, Medical
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.
FDA root cause: Under Investigation by firm
Action: The firm notified their consignees about the issue on 01/04/2019 and will install additional fixation.
Quantity in commerce: 2 units
Distribution: TX and WI, Germany, Denmark, Netherlands, United Kingdom
Product codes and lots: Serial Numbers: 1536549, 1536549

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0706-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0706-2019	Class II	Completed	Voluntary: Firm initiated	2019-01-16	2019-01-09

Product code IYE

K182076Class IIElekta UnityElekta Limited / cleared 2018-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)