FDA recall Z-0706-2019

Product

Elekta Unity

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.

Distribution

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

Key facts

Status

Completed

Initiation date

2019-01-04

Report date

2019-01-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crawley, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0706-2019