FDA Medical Device Recalls (openFDA)
Elekta Limited: Elekta Unity
- Recall number
- Z-0706-2019
- Recalling firm
- Elekta Limited
- Product
- Elekta Unity
- Status
- Completed
- Initiated
- 2019-01-04
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- Under Investigation by firm
- Action
- The firm notified their consignees about the issue on 01/04/2019 and will install additional fixation.
- Quantity
- 2 units
- Distribution
- TX and WI, Germany, Denmark, Netherlands, United Kingdom
- Lot, serial or model codes
- Serial Numbers: 1536549, 1536549
- 510(k) numbers
- ["K182076"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3002806900
- Firm city
- Crawley
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28