Elekta Limited: Medical Device Recall in 2019 - (Recall #: Z-0706-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Elekta Unity

Product Classification:

Class II

Date Initiated: January 4, 2019

Date Posted: January 16, 2019

Recall Number: Z-0706-2019

Event ID: 81886

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.

Status: Completed

Product Quantity: 2 units

Code Information:

Serial Numbers: 1536549, 1536549

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated