FDA Device

Elekta Unity

Hazard

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.

What You Should Do

Remedy

The firm notified their consignees about the issue on 01/04/2019 and will install additional fixation.

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Products

Elekta Unity
Brand
Elekta Limited Linac House Fleming Way Crawley United Kingdom
UPC
Serial Numbers: 1536549, 1536549

Units Affected

2 units

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