Elekta Unity 1536549
by Elekta Inc.
Elekta Unity 1536549 is a Class II device made by Elekta Inc., cleared under FDA 510(k) K182076 on 4 Dec 2018 and listed in FDA GUDID since 25 Jan 2019 (UDI-DI 05060191071321), active as of 22 Oct 2026. 4 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05060191071321 | Date25 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182076 | Date4 Dec 2018 | StatusActive |
Official records
- AccessGUDID record 05060191071321
- FDA 510(k) database K182076
Across registries
- FDA 510(k) K182076 decided 4 Dec 2018 Active
- FDA GUDID UDI-DI 05060191071321 listed 25 Jan 2019 Listed
Recalls
-
- Terminated Z-1980-2019
The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.
-
- Terminated Z-1297-2019
There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.
-
- Terminated Z-1109-2019
Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
-
- Completed Z-0706-2019
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.
Timeline
- Cleared FDA 510(k) K182076
- Recall initiated FDA recalls Z-0706-2019
- Listed FDA GUDID 05060191071321
- Recall initiated FDA recalls Z-1109-2019
- Recall initiated FDA recalls Z-1297-2019
- Recall initiated FDA recalls Z-1980-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Elekta Unity
- Generic name
- Linear accelerator system
- Model / reference
- 1536549
- Primary DI / UDI-DI
- 05060191071321
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Linear accelerator system
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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