Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from v
FDA device recall Z-2697-2017 · posted 2017-05-31 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing maintenance on the X-ray generator.
- Action taken
- Elekta sent an Urgent Important Field Safety Notice dated June 2017, to all affected customers. This notice informs users of the specific product and version numbers affected by the issue. The affected devices are spare part Gantry Module (item number 1515698). Customers are also instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative. For further questions, please call (770) 670-2422.
- Root cause
- Other
- Status
- Terminated
- Product code
- IWB
- Quantity affected
- 2
- Distribution
- US Distribution to the states of : NY and PA.
- Date initiated
- 2017-05-23
- Date posted
- 2017-05-31
- Date terminated
- 2017-10-18
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Leksell Gamma Knife Icon (K160440) | Elekta Instrument AB | 2016-04-20 |