Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy tre
FDA device recall Z-1297-2019 · posted 2019-05-08 · Terminated
Recall details
- Recalling firm
- Elekta Limited
- Reason for recall
- 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.
- Action taken
- Elekta notified customers on about 04/03/2019 via email with "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter. Instructions included to ensure all staff working with Elekta Unity are aware of the issue and recall information and post the recall notice in a place accessible to all users, e.g. Instructions for use, until the recall is closed. Additionally customer were asked to complete and return the Acknowledgement Form.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 9 devices
- Distribution
- Worldwide Distribution - US Nationwide in the states of Texas and Wisconsin. Distribution internationally to Denmark, England, Germany, Italy, Netherlands
- Date initiated
- 2019-04-03
- Date posted
- 2019-05-08
- Date terminated
- 2023-05-01
- Location
- Crawley, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Elekta Unity (K182076) | Elekta Limited | 2018-12-04 |