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Recall Observatory FDA recall evidence

Device product

Elekta Unity

Z-0706-2019

January 04, 2019

Class II

Product summary

Firm
Elekta Limited
Event
Event 81886
Status
Completed
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0706-2019

Official wording

Reason: 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.

Code information: Serial Numbers: 1536549, 1536549

Distribution pattern: TX and WI, Germany, Denmark, Netherlands, United Kingdom

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.