Recall Z-0706-2019— Elekta Limited
Class II · Completed
Class II FDA medical device recall by Elekta Limited, initiated 2019-01-04. It names one FDA 510(k) clearance: K182076. Product: Elekta Unity. 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..
- Recalling firm
- Elekta Limited
- Classification
- Class II
- Status
- Completed
- Initiated
- 2019-01-04
- Firm location
- Crawley, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.