FDA Medical Device Recalls (openFDA)
Elekta Instrument AB: Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
- Recall number
- Z-1412-2019
- Recalling firm
- Elekta Instrument AB
- Product
- Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
- Status
- Open, Classified
- Initiated
- 2018-06-27
- Posted
- not on file
- Terminated
- not on file
- Reason
- The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
- Root cause
- Software design
- Action
- Elekta initially notified customers on about 06/27/2018 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" LETTER. Instructions included to post the recall notice in a place accessible to all users, e.g. Instructions for Use, until the recall action is closed, advise the appropriate personnel working with the affected device of the recall and the content of the recall notification letter, and complete and return the Acknowledgement Form. Elekta updated their recall strategy on about 11/21/2018 and will be providing all affected customers with software upgrade 11.1.1. Electa service engineers will be pro-actively reaching out to customers to organize a date for installation on all affected devices. An updated recall notification was not sent to customers.
- Quantity
- 52 devices
- Distribution
- Worldwide Distribution - US Nationwide distribution to GA, MD, NJ, PA, PR, WA. International distribution to Australia, Belgium, France, Germany, Hong Kong, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Romania, Russian Federation, Spain, Turkey, United Kingdom.
- Lot, serial or model codes
- Software Version 11.1
- 510(k) numbers
- ["K173791"]
- PMA numbers
- not on file
- Product code
- IWB
- Firm FEI
- 3002806883
- Firm city
- Stockholm
- Firm state
- not on file
- Firm country
- Sweden
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