Elekta Unity
FDA Recall Z-0706-2019 · Posted None
Recalling FirmElekta Limited
Recall StatusCompleted
Product CodeIYE
Date Initiated2019-01-04
Product Quantity2 units
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.
Firm Action
The firm notified their consignees about the issue on 01/04/2019 and will install additional fixation.
Root Cause
Under Investigation by firm
Distribution Pattern
TX and WI, Germany, Denmark, Netherlands, United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.