Recall Z-1412-2019 ยท IWB System, Radiation Therapy, Radionuclide
Elekta Instrument AB
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
| Date | Jun 27, 2018 |
| Status | Open, Classified |
| 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 engineer |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173791 | Leksell GammaPlan Elekta Instrument AB, Feb 9, 2018 |